# Siemens Healthcare Diagnostics Products GmbH

- Location (FDA's records): Marburg, DE
- FDA decisions: 28 (2002–2026): 23 510(k) clearances, 1 De Novo grant and 4 original PMA approvals
- Names in FDA's records: Siemens Healthcare Diagnostics Products GmbH (19); Siemens Healthcare Diagnostics Products, Ltd. (9)
- Product codes: JPA (6), DFH (6), SEI (3), GGP (2), CGR (2), LOM (1), MOI (1), QTY (1), LTK (1), NDY (1), NQD (1), QLU (1)
- 510(k) review time since 2016: median 113 days, against 114 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 33 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dade Behring, Inc.: 10 (https://510kreport.com/company/dade-behring)
- Diagnostic Products Corp.: 6 (https://510kreport.com/company/diagnostic-products)
- The Binding Site, Ltd.: 4 (https://510kreport.com/company/binding-site)
- Instrumentation Laboratory CO: 3 (https://510kreport.com/company/instrumentation-laboratory)
- Diagnostica Stago, Inc.: 1 (https://510kreport.com/company/diagnostica-stago)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K182098: N Latex FLC kappa assay, N Latex FLC lambda assay (2018), cited by 2
- K171742: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 (2017), cited by 2
- K171072: N Latex Cystatin C; N Protein Standard UY (2017), cited by 1
- K212559: CardioPhase® hsCRP (2022), cited by 1
- K193047: N Latex FLC kappa, N Latex FLC lambda (2021), cited by 1
- K201496: N Latex FLC kappa, N Latex FLC lambda (2021), cited by 1

## Recent decisions
- K260331: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) (Sep 4, 2026)
- K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (Oct 10, 2024)
- K233946: Immulite® 2000 BR-MA (Mar 13, 2024)
- K233663: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (Dec 13, 2023)
- K213510: Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA (Sep 8, 2023)
- K220728: vWF Ag (Jun 2, 2023)
- K212559: CardioPhase® hsCRP (Dec 16, 2022)
- DEN200067: INNOVANCE VWF Ac (Sep 29, 2022)

Source page: https://510kreport.com/company/siemens-healthcare-diagnostics-products