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. Immunology ✕
10 devices
Cleared
Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
Immunology
82d
Cleared
Aug 18, 1998
ROCHE CRP T CONTROL N
Immunology
64d
Cleared
Jul 23, 1996
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
Immunology
74d
Cleared
Dec 21, 1995
ROCHE CONTROL SERUM N
Immunology
72d
Cleared
Dec 21, 1995
ROCHE CONTROL SERUM P
Immunology
72d
Cleared
Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
Immunology
164d
Cleared
Jun 19, 1992
COBAS CORE FERRITIN EIA
Immunology
116d
Cleared
May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
Immunology
90d
Cleared
May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
Immunology
89d
Cleared
May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
Immunology
89d