Chrysalis Intelligence · Sponsors · Perkinelmer, Inc.

Perkinelmer, Inc.

Waltham, MA, US · 3 510(k) clearances

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Total clearances
3
2020-02-07 → 2022-11-09
Last 12 months
0
Product codes
3
Most recent
2022-11-09
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QUE Spinal Muscular Atrophy Newborn Screening Test System Class II Immunology 1 2022-11-09
PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System Class II Immunology 1 2022-11-09
NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Class II Clinical Chemistry 1 2020-02-07
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2022-11-09 K203035 Eonis SCID-SMA kit PJI Class II Immunology
2022-11-09 DEN200044 Eonis SCID-SMA Kit QUE Class II Immunology
2020-02-07 K193103 NeoBase 2 Non-derivatized MSMS Kit NQL Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence