Siemens Healthcare Diagnostics Products GmbH - FDA 510(k) Cleared Dev...
19
Total
18
Cleared
1
Denied
FDA 510(k) cleared devices by Siemens Healthcare Diagnostics... Hematology ✕
10 devices
Cleared
Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
Hematology
251d
Cleared
Jun 02, 2023
vWF Ag
Hematology
445d
Not Cleared
Sep 29, 2022
INNOVANCE VWF Ac
Hematology
701d
Cleared
Sep 07, 2018
INNOVANCE Free PS Ag
Hematology
88d
Cleared
Oct 31, 2017
Sysmex CS-5100
Hematology
90d
Cleared
Dec 26, 2016
Sysmex CS-2100i
Hematology
90d
Cleared
Dec 12, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
Hematology
104d
Cleared
Sep 02, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
Hematology
114d
Cleared
Sep 01, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
Hematology
114d
Cleared
Jan 26, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
Hematology
259d