Medical Device Manufacturer · US , Somerville , NJ

Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices

53 submissions · 50 cleared · Since 1993
53
Total
50
Cleared
3
Denied
53 devices
51-53 of 53
Cleared Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507 · MKZ
Microbiology · 217d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506 · JJF
Chemistry · 194d
Cleared Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906 · MKZ
Microbiology · 363d
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