# Siemens Healthcare Diagnostic Products GmbH

- Location (FDA's records): Marburg, DE
- FDA decisions: 5 (2016–2026): 5 510(k) clearances
- Product codes: JPA (2), DCN (1), JBQ (1), DAP (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dade Behring, Inc.: 2 (https://510kreport.com/company/dade-behring)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Behring Diagnostics, Inc.: 1 (https://510kreport.com/company/behring-diagnostics)

## Firms that cite its devices most
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)

## Its most-cited devices
- K150678: Sysmex Automated Blood Coagulation Analyzer CS-5100 (2016), cited by 1

## Recent decisions
- K253985: INNOVANCE® D-Dimer 2.0 (SMN 10873803) (Aug 11, 2026)
- K242952: INNOVANCE Antithrombin (Mar 28, 2025)
- K232624: CardioPhase® hsCRP (Nov 27, 2023)
- K172286: Automated Blood Coagulation Analyzer CS-2500 (Dec 18, 2017)
- K150678: Sysmex Automated Blood Coagulation Analyzer CS-5100 (Jan 11, 2016)

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