Medical Device Manufacturer · US , Indianapolis , IN

Roche Diagnostics Corp. - FDA 510(k) Cleared Devices

264 submissions · 263 cleared · Since 1999

264

Total

263

Cleared

1

Denied

FDA 510(k) cleared devices by Roche Diagnostics Corp. Microbiology ✕

7 devices

1-7 of 7

Cleared Nov 10, 2009

ELECSYS TOXO IGG CALCHECK 5

Microbiology · 50d

Cleared Dec 05, 2008

ELECSYS RUBELLA IGG IMMUNOASSAY

Microbiology · 445d

Cleared Jun 09, 2008

ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG

Microbiology · 179d

Cleared Aug 10, 2006

COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

Microbiology · 258d

Cleared Aug 10, 2006

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Microbiology · 258d

Cleared Nov 30, 2001

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

Microbiology · 184d

Cleared Dec 20, 1999

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

Microbiology · 101d