Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES, MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES, MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
296
Total
296
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roche Diagnostic Systems, Inc. Microbiology ✕
5 devices
Cleared
Apr 05, 1993
ROCHE OXI/FERM II
Microbiology
272d
Cleared
Sep 11, 1992
ROCHE ENTEROTUBE II
Microbiology
102d
Cleared
Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
Microbiology
231d
Cleared
Apr 22, 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
Microbiology
26d
Cleared
Apr 22, 1985
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
Microbiology
26d