Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices
55
Total
52
Cleared
3
Denied
55 devices
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
May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
Chemistry
194d
Cleared
Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Microbiology
363d