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Roche Diagnostic Systems, Inc.

296 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
COBAS READY CK REAGENT (K896240)Roche Diagnostic Systems, Inc.1990-02-16
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) (K895906)Roche Diagnostic Systems, Inc.1990-01-26
COBAS READY (K896007)Roche Diagnostic Systems, Inc.1989-12-19
ISOSCREEN-CK CONFIRMATORY KIT (K895870)Roche Diagnostic Systems, Inc.1989-12-01
COBAS READY GLUCOSE REAGENT (K895526)Roche Diagnostic Systems, Inc.1989-10-16
ROCHE REAGENT FOR URIC ACID (K894101)Roche Diagnostic Systems, Inc.1989-09-05
ROCHO ISOMUNE - LD (K894081)Roche Diagnostic Systems, Inc.1989-08-31
ABUSCREEN POSITIVE REFERENCE CONTROLS (K894464)Roche Diagnostic Systems, Inc.1989-08-28
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS (K894463)Roche Diagnostic Systems, Inc.1989-08-21
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K894465)Roche Diagnostic Systems, Inc.1989-08-15
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS (K891581)Roche Diagnostic Systems, Inc.1989-08-15
ROCHE REAGENT FOR TRIGLYCERIDES (K893973)Roche Diagnostic Systems, Inc.1989-08-11
COBAS FARA II CENTRIFUGAL ANALYZER (K893854)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE (K893856)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC (K893858)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES (K893855)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE (K893859)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE (K893860)Roche Diagnostic Systems, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE (K893857)Roche Diagnostic Systems, Inc.1989-08-03
COBAS FARA CENTRIFUGAL ANALYZER (K893641)Roche Diagnostic Systems, Inc.1989-07-20
ROCHE(R) CARDIOSCREEN-CK (K891462)Roche Diagnostic Systems, Inc.1989-05-22
ABUSCREEN FP BENZODIAZEPHINE REAGENT (K891697)Roche Diagnostic Systems, Inc.1989-03-31
ROCHE CHLORIDE ELECTRODE (K890528)Roche Diagnostic Systems, Inc.1989-03-31
COBAS MFC (K885292)Roche Diagnostic Systems, Inc.1989-03-22
ABUSCREEN FP FOR CANNABINOIDS (K890887)Roche Diagnostic Systems, Inc.1989-03-16
ABUSCREEN FP FOR MORPHINE (K890888)Roche Diagnostic Systems, Inc.1989-03-15
ABUSCREEN FP BUFFER REAGENT (K890883)Roche Diagnostic Systems, Inc.1989-03-15
ABUSCREEN FP FOR PHENCYCLIDINE (K890882)Roche Diagnostic Systems, Inc.1989-03-15
ABUSCREEN FP FOR COCAINE METABOLITE (K890885)Roche Diagnostic Systems, Inc.1989-03-13
ABUSCREEN FP FOR AMPHETAMINE (K890886)Roche Diagnostic Systems, Inc.1989-03-10
ABUSCREEN FP FOR BARBITURATES (K890884)Roche Diagnostic Systems, Inc.1989-03-09
ROCHE REAGENT FOR CHLORIDE (K884013)Roche Diagnostic Systems, Inc.1988-12-09
ROCHE REAGENT FOR INORGANIC PHOSPHORUS (K883962)Roche Diagnostic Systems, Inc.1988-11-29
ROCHE REAGENT FOR CALCIUM (K883453)Roche Diagnostic Systems, Inc.1988-10-25
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE (K882496)Roche Diagnostic Systems, Inc.1988-09-02
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE (K881815)Roche Diagnostic Systems, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (K881817)Roche Diagnostic Systems, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR THC (K881814)Roche Diagnostic Systems, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES (K881816)Roche Diagnostic Systems, Inc.1988-07-28
COBAS EIA(TM) PHOTOMETER (K881877)Roche Diagnostic Systems, Inc.1988-06-10
ABUSCREEN(R) EIA AMPHETAMINE (K874836)Roche Diagnostic Systems, Inc.1988-02-16
FRUCTOSAMINE TEST (ROCHE) (K854010)Roche Diagnostic Systems, Inc.1987-12-22
REVISED LABELING FOR CANNABINOIDS TEST KIT (K874269)Roche Diagnostic Systems, Inc.1987-11-20
REVISED LABELING FOR LSD TEST KIT (K874270)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR BENZODIAZEPINE TEST KIT (K874265)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR METHAQUALONE TEST KIT (K874272)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR AMPHETAMINE TEST KIT (K874274)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR PCP TEST KIT (K874267)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE (K874210)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR MORPHINE TEST KIT (K874268)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR COCAINE/COCAINE META. TEST (K874271)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR BARBITURATE TEST KIT (K874266)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR AMPHETAMINE TEST KIT (K874273)Roche Diagnostic Systems, Inc.1987-11-13
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL (K873250)Roche Diagnostic Systems, Inc.1987-10-20
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (K872397)Roche Diagnostic Systems, Inc.1987-07-21
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (K871680)Roche Diagnostic Systems, Inc.1987-06-08
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (K871484)Roche Diagnostic Systems, Inc.1987-05-28
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES (K870994)Roche Diagnostic Systems, Inc.1987-03-24
ABUSCREEN (R) EIA CANNABINOIDS (K870377)Roche Diagnostic Systems, Inc.1987-03-16
COCAINE METABOLITE ROCHE(R) EIA (K863843)Roche Diagnostic Systems, Inc.1987-03-16
ABUSCREEN (R) EIA BARBITURATE (K870378)Roche Diagnostic Systems, Inc.1987-03-16
MORPHINE ROCHE (R) EIA TEST (K864168)Roche Diagnostic Systems, Inc.1987-03-16
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (K860525)Roche Diagnostic Systems, Inc.1986-04-11
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT (K853009)Roche Diagnostic Systems, Inc.1986-03-04
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (K854009)Roche Diagnostic Systems, Inc.1985-10-15
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (K853010)Roche Diagnostic Systems, Inc.1985-08-07
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA (K852473)Roche Diagnostic Systems, Inc.1985-07-12
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR (K852320)Roche Diagnostic Systems, Inc.1985-07-09
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (K852317)Roche Diagnostic Systems, Inc.1985-06-25
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS (K852318)Roche Diagnostic Systems, Inc.1985-06-25
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS (K852319)Roche Diagnostic Systems, Inc.1985-06-25
COBAS CALIBRATOR SERUM (K850859)Roche Diagnostic Systems, Inc.1985-05-10
COBAS MIRA (K851172)Roche Diagnostic Systems, Inc.1985-05-02
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH (K851250)Roche Diagnostic Systems, Inc.1985-04-22
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC (K851249)Roche Diagnostic Systems, Inc.1985-04-22
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C (K851032)Roche Diagnostic Systems, Inc.1985-04-03
COBAS FP REAGENTS FOR QUINIDINE (K850808)Roche Diagnostic Systems, Inc.1985-03-25
COBAS FP REAGENTS FOR CARBAMAZEPINE (K850807)Roche Diagnostic Systems, Inc.1985-03-22
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS (K850334)Roche Diagnostic Systems, Inc.1985-03-14
ROCHE STANDARDS FOR CHLORIDE & CO2 (K850396)Roche Diagnostic Systems, Inc.1985-02-27
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (K843828)Roche Diagnostic Systems, Inc.1985-02-01
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL (K843826)Roche Diagnostic Systems, Inc.1985-02-01
COBAS REAGENTS PHENOBARBITAL & PHENOBAR (K843825)Roche Diagnostic Systems, Inc.1985-02-01
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR (K843824)Roche Diagnostic Systems, Inc.1985-02-01
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (K843827)Roche Diagnostic Systems, Inc.1985-02-01
ROCHE REAGENTS REAGENT FOR CO2 (K844987)Roche Diagnostic Systems, Inc.1985-01-18
ROCHE REAGENTS REAGENT FOR URIC ACID (K844986)Roche Diagnostic Systems, Inc.1985-01-18
COBAS FLUORESCENCE POLARIZATION MODULE (K843914)Roche Diagnostic Systems, Inc.1984-11-27
ROCHE REAGENT FOR AST (K843109)Roche Diagnostic Systems, Inc.1984-11-05
COBAS FP TDM CONTROLS (K843913)Roche Diagnostic Systems, Inc.1984-10-30
COBAS-FIBRO (K842717)Roche Diagnostic Systems, Inc.1984-10-17
ROCHE REAGENT FOR ALT (K843111)Roche Diagnostic Systems, Inc.1984-10-05
ROCHE STANDARDS FOR URIC ACID (K843112)Roche Diagnostic Systems, Inc.1984-09-13
ROCHE STANDARDS FOR CHOLESTEROL (K843110)Roche Diagnostic Systems, Inc.1984-09-04
CK-NAC REAGENT (K834502)Roche Diagnostic Systems, Inc.1984-02-27
COBAS STANDARDS FOR GLUCOSE & BUN (K831030)Roche Diagnostic Systems, Inc.1983-05-09
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