Medical Device Manufacturer · US , Mchenry , IL

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

296 submissions · 296 cleared · Since 1983
296
Total
296
Cleared
0
Denied
296 devices
226-250 of 296
Cleared Mar 15, 1989
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · LCL
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · DIO
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP FOR MORPHINE
K890888 · DJG
Toxicology · 22d
Cleared Mar 13, 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · DIO
Toxicology · 20d
Cleared Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · DKZ
Toxicology · 17d
Cleared Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · DIS
Toxicology · 16d
Cleared Dec 09, 1988
ROCHE REAGENT FOR CHLORIDE
K884013 · CHJ
Chemistry · 78d
Cleared Nov 29, 1988
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
K883962 · CEO
Chemistry · 70d
Cleared Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
K883453 · CJY
Chemistry · 74d
Cleared Sep 02, 1988
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · DJG
Toxicology · 77d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · LDJ
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · DIO
Toxicology · 92d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817 · DJP
Toxicology · 92d
Cleared Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
K881816 · DKN
Toxicology · 91d
Cleared Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
K881877 · JJQ
Chemistry · 37d
Cleared Feb 16, 1988
ABUSCREEN(R) EIA AMPHETAMINE
K874836 · DKZ
Toxicology · 84d
Cleared Dec 22, 1987
FRUCTOSAMINE TEST (ROCHE)
K854010 · LCP
Chemistry · 813d
Cleared Nov 20, 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
K874269 · LDJ
Toxicology · 31d
Cleared Nov 13, 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210 · DIS
Toxicology · 28d
Cleared Nov 13, 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265 · JXM
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR BARBITURATE TEST KIT
K874266 · DIS
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR PCP TEST KIT
K874267 · LCM
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR MORPHINE TEST KIT
K874268 · DJG
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR LSD TEST KIT
K874270 · DLB
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR COCAINE/COCAINE META. TEST
K874271 · DIO
Toxicology · 24d

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