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Roche Diagnostic Systems, Inc.

296 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS (K932753)Roche Diagnostic Systems, Inc.1993-07-22
ABUSCREEN CALIBRATION STANDARD (K932754)Roche Diagnostic Systems, Inc.1993-07-22
ROCHE CARDIOTROL-CK (K930889)Roche Diagnostic Systems, Inc.1993-07-06
COBAS CORE LH EIA (K930306)Roche Diagnostic Systems, Inc.1993-05-26
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI (K926441)Roche Diagnostic Systems, Inc.1993-05-26
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS (K926443)Roche Diagnostic Systems, Inc.1993-05-20
ROCHE ABUSCREEN ONTRAK FOR METHADONE (K930845)Roche Diagnostic Systems, Inc.1993-04-20
ROCHE OXI/FERM II (K923313)Roche Diagnostic Systems, Inc.1993-04-05
COBAS-FP TDM CONTROLS (K930269)Roche Diagnostic Systems, Inc.1993-02-25
ROCHE COBAS FUTURA GLUCOSE (K922811)Roche Diagnostic Systems, Inc.1993-01-27
ROCHE REAGENT FOR AST (K924244)Roche Diagnostic Systems, Inc.1993-01-04
ABUSCREEN ONLINE FOR COCAINE METABOLITE (K924113)Roche Diagnostic Systems, Inc.1992-12-28
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS (K925003)Roche Diagnostic Systems, Inc.1992-12-03
ROCHE REAGENT FOR GGT (K924246)Roche Diagnostic Systems, Inc.1992-11-18
ROCHE REAGENT FOR ALT (K924245)Roche Diagnostic Systems, Inc.1992-10-22
ROCHE ENTEROTUBE II (K922588)Roche Diagnostic Systems, Inc.1992-09-11
ROCHE ABUSCREEN ONLINNE CALIBRATORS (K923340)Roche Diagnostic Systems, Inc.1992-08-04
COBAS CORE IMMUNOCHEMISTRY SYSTEM (K921180)Roche Diagnostic Systems, Inc.1992-07-28
ROCHE REAGENT FOR URIC ACID--MODIFICATION (K922762)Roche Diagnostic Systems, Inc.1992-07-09
COBAS CORE FERRITIN EIA (K920829)Roche Diagnostic Systems, Inc.1992-06-19
ROCHE CALIBRATOR SERUM (K922043)Roche Diagnostic Systems, Inc.1992-06-16
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED (K921998)Roche Diagnostic Systems, Inc.1992-05-26
ROCHE COBAS MIRA PLUS (K920402)Roche Diagnostic Systems, Inc.1992-04-29
ABUSCREEN ONLINE FOR PHENCYCLIDINE (K920935)Roche Diagnostic Systems, Inc.1992-03-18
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL (K915516)Roche Diagnostic Systems, Inc.1992-01-28
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR (K914750)Roche Diagnostic Systems, Inc.1991-11-22
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL (K914806)Roche Diagnostic Systems, Inc.1991-11-19
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET (K913911)Roche Diagnostic Systems, Inc.1991-11-01
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES (K914509)Roche Diagnostic Systems, Inc.1991-11-01
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES (K914468)Roche Diagnostic Systems, Inc.1991-10-30
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K912754)Roche Diagnostic Systems, Inc.1991-09-27
ROCHE COBAS ARGOS 5 DIFF (K912615)Roche Diagnostic Systems, Inc.1991-09-27
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (K913414)Roche Diagnostic Systems, Inc.1991-09-25
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (K913722)Roche Diagnostic Systems, Inc.1991-09-10
ABUSCREEN(R) ONLINE(TM) CONTROLS (K913336)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (K912755)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN(R) ONLINE(TM) CALIBRATORS (K913335)Roche Diagnostic Systems, Inc.1991-08-26
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ (K913107)Roche Diagnostic Systems, Inc.1991-08-12
ROCHE REAGENT FOR ETHANOL (K913125)Roche Diagnostic Systems, Inc.1991-08-12
ROCHE REAGENT FOR AMMONIA (K913124)Roche Diagnostic Systems, Inc.1991-08-12
ABUSCREEN ONLINE FOR THC (50 AND 100) (K912574)Roche Diagnostic Systems, Inc.1991-08-12
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (K912756)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS (K912757)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN ONLINE FOR AMPHETAMINES (K912758)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS (K912048)Roche Diagnostic Systems, Inc.1991-07-26
ROCHE REAGENT FOR C02 (K911838)Roche Diagnostic Systems, Inc.1991-07-19
ABUSCREEN FP FOR CANNABINOIDS (15-50) (K910592)Roche Diagnostic Systems, Inc.1991-06-21
ROCHE APOLIPOPROTEIN STANDARD (K910553)Roche Diagnostic Systems, Inc.1991-05-08
ROCHE REAGENT FOR APOLIPOPROTEIN B (K910552)Roche Diagnostic Systems, Inc.1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN A-1 (K910551)Roche Diagnostic Systems, Inc.1991-05-07
ROCHE REAGENT FOR DIRECT BILIRUBIN (K910593)Roche Diagnostic Systems, Inc.1991-04-24
ROCHE REAGENT FOR TOTAL BILIRUBIN (K910591)Roche Diagnostic Systems, Inc.1991-04-24
ABUSCREEN ONTRAK FOR BENZODIAZEPINE (K910590)Roche Diagnostic Systems, Inc.1991-04-05
ABUSCREEN FP FOR CANNABINOIDS (50-100) (K910589)Roche Diagnostic Systems, Inc.1991-04-03
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) (K910278)Roche Diagnostic Systems, Inc.1991-04-03
ABUSCREEN ONTRAK FOR METHAMPHETAMINE (K910658)Roche Diagnostic Systems, Inc.1991-04-03
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS (K910085)Roche Diagnostic Systems, Inc.1991-03-11
ABUSCREEN(R) ONLINE CONTROLS (K910689)Roche Diagnostic Systems, Inc.1991-03-11
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000) (K910756)Roche Diagnostic Systems, Inc.1991-03-11
COBAS ALPHA (K910222)Roche Diagnostic Systems, Inc.1991-02-27
ABUSCREEN(R) ONLINE CALIBRATORS (K905828)Roche Diagnostic Systems, Inc.1991-02-04
ABUSCREEN ONLINE OPIATES CALIBRATORS (K910087)Roche Diagnostic Systems, Inc.1991-02-04
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS (K910086)Roche Diagnostic Systems, Inc.1991-01-17
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (K905730)Roche Diagnostic Systems, Inc.1991-01-15
ABUSCREEN ONLINE TM FOR THC (K904996)Roche Diagnostic Systems, Inc.1991-01-11
ABUSCREEN ONLINE TM FOR OPIATES (K904997)Roche Diagnostic Systems, Inc.1990-12-27
ABUSCREEN ONTRAK FOR THC (K904856)Roche Diagnostic Systems, Inc.1990-12-13
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (K904995)Roche Diagnostic Systems, Inc.1990-11-28
ROCHE COBAS READY GGT REAGENT (K903304)Roche Diagnostic Systems, Inc.1990-10-12
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (K904049)Roche Diagnostic Systems, Inc.1990-10-12
ROCHE COBAS READY HDL CHOLESTEROL REAGENT (K902935)Roche Diagnostic Systems, Inc.1990-09-27
ROCHE COBAS READY CREATININE REAGENT (K902561)Roche Diagnostic Systems, Inc.1990-09-07
ROCHE COBAS READY AMYLASE REAGENT (K903309)Roche Diagnostic Systems, Inc.1990-09-07
COBAS READY CALCIUM REAGENT (K896224)Roche Diagnostic Systems, Inc.1990-08-17
ROCHE ISOMUNE- CK (K903025)Roche Diagnostic Systems, Inc.1990-08-09
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT (K902560)Roche Diagnostic Systems, Inc.1990-07-17
COBAS READY CALIBRATOR KIT (K897097)Roche Diagnostic Systems, Inc.1990-06-26
COBAS READY PROFILE 2 REAGENT STRIP (K896225)Roche Diagnostic Systems, Inc.1990-06-26
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY (K900718)Roche Diagnostic Systems, Inc.1990-06-12
ROTAG CONTROLS (K900719)Roche Diagnostic Systems, Inc.1990-05-30
ROCHE REAGENT FOR MAGNESIUM (K901758)Roche Diagnostic Systems, Inc.1990-05-23
COBAS-FP REAGENTS FOR VANCOMYCIN (K901759)Roche Diagnostic Systems, Inc.1990-05-02
ROCHE REAGENT FOR LDH (K900121)Roche Diagnostic Systems, Inc.1990-03-30
ROCHE STANDARDS FOR THE COBAS ISE MODULE (K897071)Roche Diagnostic Systems, Inc.1990-03-09
ABUSCREEN FP FOR METHAMPHETAMINE (K900143)Roche Diagnostic Systems, Inc.1990-03-09
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL (K900120)Roche Diagnostic Systems, Inc.1990-03-09
COBAS READY ALBUMIN REAGENT (K896235)Roche Diagnostic Systems, Inc.1990-02-27
COBAS READY TOTAL BILIRUBIN REAGENT (K896232)Roche Diagnostic Systems, Inc.1990-02-27
COBAS READY BUN REAGENT (K896236)Roche Diagnostic Systems, Inc.1990-02-27
COBAS READY PROFILE 1 REAGENT STRIP (K896229)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY STAT PROFILE REAGENT STRIP (K896234)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY ALT REAGENT (K896237)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY TRIGLYCERIDE REAGENT (K896231)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY URIC ACID REAGENT (K896227)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY TOTAL PROTEIN REAGENT (K896230)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY AST REAGENT (K896238)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY CHOLESTEROL REAGENT (K896239)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY CARDIO PROFILE REAGENT STRIP (K896228)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LDH REAGENT (K896241)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LIVER PROFILE REAGENT STRIP (K896233)Roche Diagnostic Systems, Inc.1990-02-16
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