Roche Diagnostic Systems, Inc.
FDA 510(k) medical device clearances.
Clearances by Roche Diagnostic Systems, Inc. — page 2
101–200 of 296- K932753 — ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
- K932754 — ABUSCREEN CALIBRATION STANDARD
- K930889 — ROCHE CARDIOTROL-CK
- K926441 — ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
- K930306 — COBAS CORE LH EIA
- K926443 — COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
- K930845 — ROCHE ABUSCREEN ONTRAK FOR METHADONE
- K923313 — ROCHE OXI/FERM II
- K930269 — COBAS-FP TDM CONTROLS
- K922811 — ROCHE COBAS FUTURA GLUCOSE
- K924244 — ROCHE REAGENT FOR AST
- K924113 — ABUSCREEN ONLINE FOR COCAINE METABOLITE
- K925003 — COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
- K924246 — ROCHE REAGENT FOR GGT
- K924245 — ROCHE REAGENT FOR ALT
- K922588 — ROCHE ENTEROTUBE II
- K923340 — ROCHE ABUSCREEN ONLINNE CALIBRATORS
- K921180 — COBAS CORE IMMUNOCHEMISTRY SYSTEM
- K922762 — ROCHE REAGENT FOR URIC ACID--MODIFICATION
- K920829 — COBAS CORE FERRITIN EIA
- K922043 — ROCHE CALIBRATOR SERUM
- K921998 — ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
- K920402 — ROCHE COBAS MIRA PLUS
- K920935 — ABUSCREEN ONLINE FOR PHENCYCLIDINE
- K915516 — ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
- K914750 — ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
- K914806 — ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
- K913911 — ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
- K914509 — ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
- K914468 — ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
- K912615 — ROCHE COBAS ARGOS 5 DIFF
- K912754 — ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
- K913414 — ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
- K913722 — ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
- K912755 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
- K913335 — ABUSCREEN(R) ONLINE(TM) CALIBRATORS
- K913336 — ABUSCREEN(R) ONLINE(TM) CONTROLS
- K912574 — ABUSCREEN ONLINE FOR THC (50 AND 100)
- K913107 — ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
- K913124 — ROCHE REAGENT FOR AMMONIA
- K913125 — ROCHE REAGENT FOR ETHANOL
- K912048 — ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
- K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
- K912757 — ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
- K912758 — ABUSCREEN ONLINE FOR AMPHETAMINES
- K911838 — ROCHE REAGENT FOR C02
- K910592 — ABUSCREEN FP FOR CANNABINOIDS (15-50)
- K910553 — ROCHE APOLIPOPROTEIN STANDARD
- K910551 — ROCHE REAGENT FOR APOLIPOPROTEIN A-1
- K910552 — ROCHE REAGENT FOR APOLIPOPROTEIN B
- K910591 — ROCHE REAGENT FOR TOTAL BILIRUBIN
- K910593 — ROCHE REAGENT FOR DIRECT BILIRUBIN
- K910590 — ABUSCREEN ONTRAK FOR BENZODIAZEPINE
- K910278 — ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
- K910589 — ABUSCREEN FP FOR CANNABINOIDS (50-100)
- K910658 — ABUSCREEN ONTRAK FOR METHAMPHETAMINE
- K910085 — ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
- K910689 — ABUSCREEN(R) ONLINE CONTROLS
- K910756 — ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
- K910222 — COBAS ALPHA
- K905828 — ABUSCREEN(R) ONLINE CALIBRATORS
- K910087 — ABUSCREEN ONLINE OPIATES CALIBRATORS
- K910086 — ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
- K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
- K904996 — ABUSCREEN ONLINE TM FOR THC
- K904997 — ABUSCREEN ONLINE TM FOR OPIATES
- K904856 — ABUSCREEN ONTRAK FOR THC
- K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
- K903304 — ROCHE COBAS READY GGT REAGENT
- K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
- K902935 — ROCHE COBAS READY HDL CHOLESTEROL REAGENT
- K902561 — ROCHE COBAS READY CREATININE REAGENT
- K903309 — ROCHE COBAS READY AMYLASE REAGENT
- K896224 — COBAS READY CALCIUM REAGENT
- K903025 — ROCHE ISOMUNE- CK
- K902560 — ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
- K896225 — COBAS READY PROFILE 2 REAGENT STRIP
- K897097 — COBAS READY CALIBRATOR KIT
- K900718 — ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
- K900719 — ROTAG CONTROLS
- K901758 — ROCHE REAGENT FOR MAGNESIUM
- K901759 — COBAS-FP REAGENTS FOR VANCOMYCIN
- K900121 — ROCHE REAGENT FOR LDH
- K897071 — ROCHE STANDARDS FOR THE COBAS ISE MODULE
- K900120 — ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
- K900143 — ABUSCREEN FP FOR METHAMPHETAMINE
- K896232 — COBAS READY TOTAL BILIRUBIN REAGENT
- K896235 — COBAS READY ALBUMIN REAGENT
- K896236 — COBAS READY BUN REAGENT
- K896227 — COBAS READY URIC ACID REAGENT
- K896228 — COBAS READY CARDIO PROFILE REAGENT STRIP
- K896229 — COBAS READY PROFILE 1 REAGENT STRIP
- K896230 — COBAS READY TOTAL PROTEIN REAGENT
- K896231 — COBAS READY TRIGLYCERIDE REAGENT
- K896233 — COBAS READY LIVER PROFILE REAGENT STRIP
- K896234 — COBAS READY STAT PROFILE REAGENT STRIP
- K896237 — COBAS READY ALT REAGENT
- K896238 — COBAS READY AST REAGENT
- K896239 — COBAS READY CHOLESTEROL REAGENT
- K896240 — COBAS READY CK REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.