Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices
49
Total
46
Cleared
3
Denied
43 devices
Cleared
Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Microbiology
27d
Cleared
May 22, 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control...
Microbiology
89d
Cleared
Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
Microbiology
90d
Cleared
Sep 12, 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
Microbiology
90d
Cleared
Feb 09, 2017
cobas® CT/NG v2.0 Test
Microbiology
87d
Cleared
Jun 01, 2015
cobas HSV 1 and 2 Test
Microbiology
83d
Cleared
May 20, 2015
cobas Cdiff Test
Microbiology
265d
Cleared
Dec 17, 2014
cobas MRSA/SA Test
Microbiology
85d
Cleared
May 05, 2014
COBAS CT/NG V2.0 TEST
Microbiology
28d
Cleared
Dec 02, 2013
COBAS CT/NG V2.0 TEST
Microbiology
133d
Cleared
Jan 24, 2012
COBAS 4800 CT / NG TEST
Microbiology
298d
Cleared
Jul 06, 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT,...
Microbiology
419d
Cleared
Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Microbiology
733d
Cleared
Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Microbiology
674d
Cleared
May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Microbiology
556d
Cleared
Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Microbiology
442d
Cleared
Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Microbiology
217d
Cleared
Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Microbiology
363d