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
126-150 of 296
Cleared Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
K914750 · JIX
Chemistry · 31d
Cleared Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · DIF
Toxicology · 26d
Cleared Nov 01, 1991
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
K913911 · DPJ
Toxicology · 63d
Cleared Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509 · JXM
Toxicology · 23d
Cleared Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
K914468 · DKN
Toxicology · 23d
Cleared Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
K912615 · GZI
Hematology · 106d
Cleared Sep 27, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K912754 · DPJ
Toxicology · 98d
Cleared Sep 25, 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
K913414 · LAT
Toxicology · 62d
Cleared Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722 · KLN
Toxicology · 25d
Cleared Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · DJP
Toxicology · 66d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
K913335 · DKB
Toxicology · 34d
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 Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
K913124 · JIF
Chemistry · 28d
Cleared Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
K913125 · DIC
Chemistry · 28d
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 Jul 19, 1991
ROCHE REAGENT FOR C02
K911838 · CHS
Chemistry · 85d
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · LDJ
Toxicology · 129d
Cleared May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
K910553 · DER
Immunology · 90d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · MSJ
Immunology · 89d
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · MSJ
Immunology · 89d

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