Roche Diagnostic Systems, Inc.
Roche Diagnostic Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 1999.
Clearances by Roche Diagnostic Systems, Inc. — page 3
201–296 of 296- K896241 — COBAS READY LDH REAGENT
- K895906 — ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
- K896007 — COBAS READY
- K895870 — ISOSCREEN-CK CONFIRMATORY KIT
- K895526 — COBAS READY GLUCOSE REAGENT
- K894101 — ROCHE REAGENT FOR URIC ACID
- K894081 — ROCHO ISOMUNE - LD
- K894464 — ABUSCREEN POSITIVE REFERENCE CONTROLS
- K894463 — ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
- K891581 — COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
- K894465 — ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
- K893973 — ROCHE REAGENT FOR TRIGLYCERIDES
- K893854 — COBAS FARA II CENTRIFUGAL ANALYZER
- K893855 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
- K893856 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
- K893857 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
- K893858 — ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
- K893859 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
- K893860 — ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
- K893641 — COBAS FARA CENTRIFUGAL ANALYZER
- K891462 — ROCHE(R) CARDIOSCREEN-CK
- K890528 — ROCHE CHLORIDE ELECTRODE
- K891697 — ABUSCREEN FP BENZODIAZEPHINE REAGENT
- K885292 — COBAS MFC
- K890887 — ABUSCREEN FP FOR CANNABINOIDS
- K890882 — ABUSCREEN FP FOR PHENCYCLIDINE
- K890883 — ABUSCREEN FP BUFFER REAGENT
- K890888 — ABUSCREEN FP FOR MORPHINE
- K890885 — ABUSCREEN FP FOR COCAINE METABOLITE
- K890886 — ABUSCREEN FP FOR AMPHETAMINE
- K890884 — ABUSCREEN FP FOR BARBITURATES
- K884013 — ROCHE REAGENT FOR CHLORIDE
- K883962 — ROCHE REAGENT FOR INORGANIC PHOSPHORUS
- K883453 — ROCHE REAGENT FOR CALCIUM
- K882496 — ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
- K881814 — ABUSCREEN(R) ONTRAK(TM) FOR THC
- K881815 — ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
- K881817 — ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
- K881816 — ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
- K881877 — COBAS EIA(TM) PHOTOMETER
- K874836 — ABUSCREEN(R) EIA AMPHETAMINE
- K854010 — FRUCTOSAMINE TEST (ROCHE)
- K874269 — REVISED LABELING FOR CANNABINOIDS TEST KIT
- K874210 — REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
- K874265 — REVISED LABELING FOR BENZODIAZEPINE TEST KIT
- K874266 — REVISED LABELING FOR BARBITURATE TEST KIT
- K874267 — REVISED LABELING FOR PCP TEST KIT
- K874268 — REVISED LABELING FOR MORPHINE TEST KIT
- K874270 — REVISED LABELING FOR LSD TEST KIT
- K874271 — REVISED LABELING FOR COCAINE/COCAINE META. TEST
- K874272 — REVISED LABELING FOR METHAQUALONE TEST KIT
- K874273 — REVISED LABELING FOR AMPHETAMINE TEST KIT
- K874274 — REVISED LABELING FOR AMPHETAMINE TEST KIT
- K873250 — ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
- K872397 — COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
- K871680 — MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
- K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
- K870994 — ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
- K863843 — COCAINE METABOLITE ROCHE(R) EIA
- K864168 — MORPHINE ROCHE (R) EIA TEST
- K870377 — ABUSCREEN (R) EIA CANNABINOIDS
- K870378 — ABUSCREEN (R) EIA BARBITURATE
- K860525 — ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
- K853009 — COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
- K854009 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
- K853010 — COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
- K852473 — ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
- K852320 — COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
- K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
- K852318 — COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
- K852319 — COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
- K850859 — COBAS CALIBRATOR SERUM
- K851172 — COBAS MIRA
- K851249 — SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
- K851250 — SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
- K851032 — COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
- K850808 — COBAS FP REAGENTS FOR QUINIDINE
- K850807 — COBAS FP REAGENTS FOR CARBAMAZEPINE
- K850334 — ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
- K850396 — ROCHE STANDARDS FOR CHLORIDE & CO2
- K843824 — COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
- K843825 — COBAS REAGENTS PHENOBARBITAL & PHENOBAR
- K843826 — COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
- K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
- K843828 — COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
- K844986 — ROCHE REAGENTS REAGENT FOR URIC ACID
- K844987 — ROCHE REAGENTS REAGENT FOR CO2
- K843914 — COBAS FLUORESCENCE POLARIZATION MODULE
- K843109 — ROCHE REAGENT FOR AST
- K843913 — COBAS FP TDM CONTROLS
- K842717 — COBAS-FIBRO
- K843111 — ROCHE REAGENT FOR ALT
- K843112 — ROCHE STANDARDS FOR URIC ACID
- K843110 — ROCHE STANDARDS FOR CHOLESTEROL
- K834502 — CK-NAC REAGENT
- K831030 — COBAS STANDARDS FOR GLUCOSE & BUN
Data sourced from openFDA. This site is unofficial and independent of the FDA.