Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
Chemistry
31d
Cleared
Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
Toxicology
26d
Cleared
Nov 01, 1991
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
Toxicology
63d
Cleared
Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
Toxicology
23d
Cleared
Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
Toxicology
23d
Cleared
Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
Hematology
106d
Cleared
Sep 27, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
Toxicology
98d
Cleared
Sep 25, 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
Toxicology
62d
Cleared
Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
Toxicology
25d
Cleared
Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
Toxicology
66d
Cleared
Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
Toxicology
34d
Cleared
Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
Toxicology
34d
Cleared
Aug 12, 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
Toxicology
61d
Cleared
Aug 12, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
Toxicology
31d
Cleared
Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
Chemistry
28d
Cleared
Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
Chemistry
28d
Cleared
Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
Toxicology
78d
Cleared
Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
Toxicology
35d
Cleared
Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
Toxicology
35d
Cleared
Jul 26, 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
Toxicology
35d
Cleared
Jul 19, 1991
ROCHE REAGENT FOR C02
Chemistry
85d
Cleared
Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
Toxicology
129d
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
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