Chrysalis Intelligence · Sponsors · Siemens Healthcare Diagnostics Products GmbH

Siemens Healthcare Diagnostics Products GmbH

Marburg, DE · 13 510(k) clearances · 21 PMAs · 2 recalls

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Total clearances
13
2021-01-15 → 2026-09-04
Last 12 months
1
Product codes
10
Most recent
2026-09-04
Name variants in FDA filings: Siemens Healthcare Diagnostics Products GmbH / Siemens Healthcare Diagnostics Products, Ltd.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DFH Kappa, Antigen, Antiserum, Control Class II Immunology 3 2022-03-02
CGR Radioimmunoassay, Cortisol Class II Clinical Chemistry 2 2021-01-15
DHB System, Test, Radioallergosorbent (Rast) Immunological Class II Immunology 1 2026-09-04
QLU Anti-Factor Xa Activity Test System, Apixaban Class II Hematology 1 2024-10-10
MOI System, Test, Immunological, Antigen, Tumor Class II Immunology 1 2024-03-13
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Class II Immunology 1 2023-12-13
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Class II Immunology 1 2023-09-08
GGP Test, Qualitative And Quantitative Factor Deficiency Class II Hematology 1 2023-06-02
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Class II Immunology 1 2022-12-16
QTY Von Willebrand Factor Assay Class II Hematology 1 2022-09-29
Class III

PMA approvals (21)

Total PMA records
21
Originals + supplements
Distinct product codes
2
First decision
2020-09-08
Most recent
2025-09-18
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-09-18 P010052-S020 IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs) 135 Review Track For 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-09-18 P010050-S026 IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit 135 Review Track For 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-09-18 P010050-S025 IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit 135 Review Track For 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-08-04 P010051-S023 IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc) 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-08-30 P010053-S015 IMMULITE® 2000 Anti-HBc IgM Special (Immediate Track) — — —
2023-08-30 P010052-S015 IMMULITE® 2000 Anti-HBs Special (Immediate Track) — — —
2023-08-30 P010051-S016 IMMULITE® 2000 Anti HBc Special (Immediate Track) — — —
2023-08-30 P010050-S020 IMMULITE® 2000 HBsAg, IMMULITE® 2000 HBsAg Confirmatory Special (Immediate Track) — — —
2022-10-14 P010053-S016 IMMULITE® 2000 Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-14 P010052-S016 IMMULITE® 2000 Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-14 P010051-S017 IMMULITE® 2000 Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-10-14 P010050-S021 IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’ 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-03-29 P010053-S014 IMMULITE 2000 Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-03-29 P010051-S015 IMMULITE 2000 Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-06-09 P010050-S019 IMMULITE 2000 HBs Ag Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-03-11 P010053-S013 IMMULITE 2000/2000 XPi Anti-HBc IgM Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-03-11 P010051-S014 IMMULITE 2000/2000 XPi Anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-09-08 P010053-S012 IMMULITE 2000 Anti-HBcM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-09-08 P010052-S014 IMMULITE 2000 Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-09-08 P010051-S013 IMMULITE 2000 Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-09-08 P010050-S018 IMMULITE 2000 HBsAg Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2026-07-13
DateSeverityStatusRecall # ProductCodeReason
2026-07-13 Class II Ongoing Z-2966-2026 Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly — Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
2026-07-13 Class II Ongoing Z-2965-2026 Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly — Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-09-04 K260331 IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) DHB Class II Immunology
2024-10-10 K240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) QLU Class II Hematology
2024-03-13 K233946 IMMULITE® 2000 BR-MA MOI Class II Immunology
2023-12-13 K233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) CFN Class II Immunology
2023-09-08 K213510 IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA LTK Class II Immunology
2023-06-02 K220728 vWF Ag GGP Class II Hematology
2022-12-16 K212559 CardioPhase® hsCRP NQD Class II Immunology
2022-09-29 DEN200067 INNOVANCE VWF Ac QTY Class II Hematology
2022-03-02 K212379 N Latex FLC kappa, N Latex FLC lambda DFH Class II Immunology
2021-10-29 K201496 N Latex FLC kappa, N Latex FLC lambda DFH Class II Immunology
2021-07-14 K193047 N Latex FLC kappa, N Latex FLC lambda DFH Class II Immunology
2021-01-15 K203270 IMMULITE/IMMULITE® 1000 Cortisol CGR Class II Clinical Chemistry
2021-01-15 K202826 IMMULITE® 2000 Cortisol CGR Class II Clinical Chemistry
Data source: openFDA · Generated 2026-09-29 10:43 · Last ingest 2026-09-29T14:43:06.673184 · Pipeline: Chrysalis Intelligence