Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Apr 24, 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
Chemistry
71d
Cleared
Apr 24, 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
Chemistry
71d
Cleared
Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
Toxicology
52d
Cleared
Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
Toxicology
70d
Cleared
Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
Toxicology
50d
Cleared
Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
Toxicology
48d
Cleared
Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
Toxicology
62d
Cleared
Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
Toxicology
20d
Cleared
Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
Toxicology
20d
Cleared
Feb 27, 1991
COBAS ALPHA
Toxicology
40d
Cleared
Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
Toxicology
48d
Cleared
Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
Toxicology
27d
Cleared
Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
Toxicology
9d
Cleared
Jan 15, 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
Toxicology
22d
Cleared
Jan 11, 1991
ABUSCREEN ONLINE TM FOR THC
Toxicology
65d
Cleared
Dec 27, 1990
ABUSCREEN ONLINE TM FOR OPIATES
Toxicology
50d
Cleared
Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
Toxicology
45d
Cleared
Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
Toxicology
21d
Cleared
Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
Chemistry
80d
Cleared
Oct 12, 1990
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
Chemistry
38d
Cleared
Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
Chemistry
86d
Cleared
Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
Chemistry
88d
Cleared
Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
Chemistry
45d
Cleared
Aug 17, 1990
COBAS READY CALCIUM REAGENT
Chemistry
291d
Cleared
Aug 09, 1990
ROCHE ISOMUNE- CK
Chemistry
30d
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