Medical Device Manufacturer · DE , Marburg

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

19 submissions · 18 cleared · Since 2016

19

Total

18

Cleared

1

Denied

FDA 510(k) cleared devices by Siemens Healthcare Diagnostics... Immunology ✕

7 devices

1-7 of 7

Cleared Dec 13, 2023

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

Immunology · 28d

Cleared Mar 02, 2022

N Latex FLC kappa, N Latex FLC lambda

Immunology · 212d

Cleared Oct 29, 2021

N Latex FLC kappa, N Latex FLC lambda

Immunology · 511d

Cleared Jul 14, 2021

N Latex FLC kappa, N Latex FLC lambda

Immunology · 621d

Cleared May 03, 2019

N Latex FLC kappa, N Latex FLC lambda

Immunology · 29d

Cleared Nov 01, 2018

N Latex FLC kappa assay, N Latex FLC lambda assay

Immunology · 90d

Cleared Nov 17, 2017

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...

Immunology · 158d