Siemens Healthcare Diagnostic Products GmbH - FDA 510(k) Cleared Devi...
Recent clearances: INNOVANCE® D-Dimer 2.0 (SMN 10873803), INNOVANCE Antithrombin, CardioPhase® hsCRP
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostic Products GmbH Hematology ✕
4 devices
Cleared
Aug 11, 2026
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
Hematology
242d
Cleared
CT
Mar 28, 2025
INNOVANCE Antithrombin
Hematology
184d
Cleared
Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
Hematology
143d
Cleared
Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
Hematology
301d