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Siemens Healthcare Diagnostic Products GmbH

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2026-08-11
TypeNumberDevice NameCodeDateActions
510(k) K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP2026-08-11 View
510(k) K242952 INNOVANCE AntithrombinJBQ2025-03-28 View
510(k) K232624 CardioPhase® hsCRPDCN2023-11-27 View
510(k) K172286 Automated Blood Coagulation Analyzer CS-2500JPA2017-12-18 View
510(k) K150678 Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11 View