Medical Device Manufacturer · DE , Marburg

Siemens Healthcare Diagnostics Products GmbH - FDA 510(k) Cleared Dev...

19 submissions · 18 cleared · Since 2016

Recent clearances: INNOVANCE Anti-Xa (OPPU05), N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), vWF Ag

19

Total

18

Cleared

1

Denied

FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics Products GmbH Chemistry ✕

2 devices

1-2 of 2

Cleared Dec 16, 2022

CardioPhase® hsCRP

Chemistry · 490d

Cleared May 12, 2017

N Latex Cystatin C

Chemistry · 32d