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
159 devices
76-100 of 159
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · LAS
Toxicology · 34d
Cleared Aug 12, 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · LAT
Toxicology · 61d
Cleared Aug 12, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · LAS
Toxicology · 31d
Cleared Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048 · DLJ
Toxicology · 78d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
K912756 · KLN
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757 · LDJ
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
K912758 · DKZ
Toxicology · 35d
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · LDJ
Toxicology · 129d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590 · JXM
Toxicology · 52d
Cleared Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · DKZ
Toxicology · 70d
Cleared Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · LDJ
Toxicology · 50d
Cleared Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · DKZ
Toxicology · 48d
Cleared Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · DKB
Toxicology · 62d
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · LAS
Toxicology · 20d
Cleared Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · DKZ
Toxicology · 20d
Cleared Feb 27, 1991
COBAS ALPHA
K910222 · JJG
Toxicology · 40d
Cleared Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · DKB
Toxicology · 48d
Cleared Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087 · DKB
Toxicology · 27d
Cleared Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · DLJ
Toxicology · 9d
Cleared Jan 15, 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · KLN
Toxicology · 22d
Cleared Jan 11, 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · LAT
Toxicology · 65d
Cleared Dec 27, 1990
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · DJG
Toxicology · 50d
Cleared Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
K904856 · LDJ
Toxicology · 45d
Cleared Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · KLN
Toxicology · 21d
Cleared Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · DKZ
Toxicology · 57d

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