Chrysalis Intelligence · Sponsors · Life Technologies Corporation

Life Technologies Corporation

Pleasanton,, CA, US · 3 510(k) clearances · 36 PMAs · 7 recalls

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Total clearances
3
2020-02-21 → 2025-01-08
Last 12 months
0
Product codes
3
Most recent
2025-01-08
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Class II Microbiology 1 2025-01-08
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Class II Microbiology 1 2024-07-10
PCA Dna Genetic Analyzer Class II Clinical Chemistry 1 2020-02-21
Class III

PMA approvals (36)

Total PMA records
36
Originals + supplements
Distinct product codes
1
First decision
2020-05-26
Most recent
2026-09-09
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-09 P240040-S005 Oncomine™ Dx Express Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2026-06-08 P240040-S006 Oncomine Dx Express Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2026-03-04 P160045-S052 Oncomine™ Dx Target Test Special (Immediate Track) PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-11-21 P160045-S051 Oncomine™ Dx Target Test Special (Immediate Track) PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-11-19 P160045-S050 Oncomine Dx Target Test Normal 180 Day Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-10-22 P240040-S003 Oncomine Dx Express Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-10-15 P240040-S002 Oncomine Dx Express Test Normal 180 Day Track No User Fee PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-08-08 P160045-S049 Oncomine Dx Target Test Normal 180 Day Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-08-07 P240040-S001 Oncomine™ Dx Express Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2025-07-02 P240040 Oncomine Dx Express Test Original PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2024-10-17 P160045-S046 Oncomine Dx Target Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2024-07-02 P160045-S048 Oncomine Dx Target Test Special (Immediate Track) PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2024-06-17 P160045-S045 Oncomine Dx Target Test Normal 180 Day Track No User Fee PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2024-06-13 P160045-S047 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-11-02 P160045-S044 Oncomine Dx Target Test Special (Immediate Track) PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-09-29 P160045-S025 Oncomine Dx Target Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-08-17 P160045-S042 Oncomine Dx Target Test Normal 180 Day Track No User Fee PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-08-10 P160045-S043 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-04-07 P160045-S041 Oncomine Dx Target Test Special (Immediate Track) PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-02-10 P160045-S040 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2023-02-01 P160045-S038 Oncomine Dx Target Test Normal 180 Day Track No User Fee PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2022-09-21 P160045-S031 Oncomine Dx Target Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2022-09-19 P160045-S037 Oncomine Dx Target Test Real-Time Process PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2022-08-11 P160045-S036 Oncomine Dx Target Test 135 Review Track For 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2022-08-11 P160045-S035 Oncomine Dx Target Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2022-01-21 P160045-S034 Oncomine Dx Target Test Normal 180 Day Track No User Fee PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2021-12-01 P160045-S027 Oncomine™ Dx Target Test Normal 180 Day Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2021-09-15 P160045-S029 Oncomine Dx Target Test (ODxT Test) Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2021-08-25 P160045-S028 Oncomine™ Dx Target Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2021-06-11 P160045-S030 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2020-12-01 P160045-S024 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2020-11-11 P160045-S023 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2020-10-23 P160045-S021 Oncomine Dx Target Test Real-Time Process PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2020-10-08 P160045-S022 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2020-09-04 P160045-S019 Oncomine Dx Target Test Panel Track PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
2020-05-26 P160045-S020 Oncomine Dx Target Test 30-Day Notice PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System Unknown
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
1
Most recent
2024-02-07
DateSeverityStatusRecall # ProductCodeReason
2024-02-07 Class II Ongoing Z-1426-2024 Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted… — Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow the…
2020-08-06 Class II Terminated Z-2979-2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the Quan… — COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burd…
2020-08-06 Class II Terminated Z-2978-2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments,… — COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burd…
2020-03-16 Class II Terminated Z-1707-2020 Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC… — Extended Expiration Date prior to clearance
2020-03-16 Class II Terminated Z-1706-2020 Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC)… — Extended Expiration Date prior to clearance
2020-03-16 Class II Terminated Z-1705-2020 Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) t… — Extended Expiration Date prior to clearance
2020-03-16 Class II Terminated Z-1704-2020 Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tu… — Extended Expiration Date prior to clearance
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-01-08 K241806 Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel QOF Class II Microbiology
2024-07-10 K233453 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit QQX Class II Microbiology
2020-02-21 K191030 Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer PCA Class II Clinical Chemistry
Data source: openFDA · Generated 2026-09-23 11:01 · Last ingest 2026-09-23T15:00:49.349277 · Pipeline: Chrysalis Intelligence