Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

177 submissions · 175 cleared · Since 2005

Official Website

177

Total

175

Cleared

2

Denied

FDA 510(k) cleared devices by Roche Diagnostics Hematology ✕

8 devices

1-8 of 8

Cleared Oct 24, 2025

CoaguChek XS Plus System

Hematology · 28d

Cleared Nov 06, 2020

cobas u 701 microscopy analyzer

Hematology · 224d

Cleared Apr 19, 2018

CoaguChek XS Plus System

Hematology · 35d

Cleared Apr 19, 2018

CoaguChek XS Pro System

Hematology · 34d

Cleared Dec 25, 2017

CoaguChek Vantus System

Hematology · 269d

Cleared Mar 18, 2010

COAGUCHEK XS PRO SYSTEM

Hematology · 132d

Cleared May 11, 2007

COAGUCHEK XS PLUS SYSTEM

Hematology · 29d

Cleared Aug 11, 2006

COAGUCHEK XS SYSTEM

Hematology · 123d