FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

55 results for "Roche Molecular Systems, Inc."
49–55 of 55
Search insights Median review: 171d Cleared: 95% Top manufacturer: Roche Molecular Systems, Inc. Lead specialty: Microbiology
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · LSL
Roche Molecular Systems, Inc.
Microbiology · 733d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 674d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342 · LSL
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 442d
Cleared Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 217d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506 · JJF
Roche Molecular Systems, Inc.
Chemistry · 194d
Cleared Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 363d