Roche Diagnostic Systems, Inc.
FDA 510(k) medical device clearances.
Top product codes for Roche Diagnostic Systems, Inc.
Recent clearances by Roche Diagnostic Systems, Inc.
1–100 of 296- K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
- K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
- K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
- K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS
- K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS
- K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
- K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
- K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
- K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
- K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
- K983174 — ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
- K983388 — ONTRAK TESTCUP-ER
- K983387 — ONTRAK TESTCUP AND TESTSTIK CONTROLS
- K982848 — COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
- K982382 — COBAS INTEGRA REAGENT CASSETTES
- K981897 — ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
- K982087 — ROCHE CRP T CONTROL N
- K982551 — ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
- K980996 — COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
- K981584 — ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
- K981585 — ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
- K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
- K974840 — ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
- K973284 — COBAS INTEGRA HDL-CHOLESTEROL DIRECT
- K973369 — ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
- K973075 — ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
- K972891 — ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
- K972250 — ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
- K972721 — ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
- K972214 — ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
- K971902 — ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
- K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
- K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES
- K964355 — ONTRAK TESTCUP 5 (MODIFICATION)
- K964422 — ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
- K963292 — COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
- K963627 — (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
- K962411 — ONTRAK TESTCUP AMPHETAMINES
- K961674 — ROCHE UNIMATE FRUCTOSAMINE REAGENT
- K962231 — COBAS CORE IMMUNOCHEMISTRY SYSTEM
- K962280 — ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
- K961824 — COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
- K961726 — ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
- K962165 — COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
- K961436 — ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
- K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
- K953847 — ROCHE REAGENT FOR GLUCOSE
- K952337 — ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
- K954992 — ROCHE COBAS INTEGRA REAGENT CASSETTES
- K954655 — ROCHE CONTROL SERUM N
- K954656 — ROCHE CONTROL SERUM P
- K954799 — ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
- K953224 — COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
- K954000 — ROCHE REAGENT FOR BUN
- K953448 — ROCHE COBAS MICROS HEMATOLOGY ANALYZER
- K942706 — ROCHE CALIBRATOR SERUM
- K953739 — ABUSCREEN ONLINE CONTROLS
- K953845 — ABUSCREEN ONLINE DRUG FREE URINE
- K952282 — ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
- K953528 — ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
- K951595 — ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
- K952555 — COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
- K951319 — ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
- K942376 — COBAS CORE FREE T3 EIA
- K945187 — ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
- K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
- K946119 — ROCHE-TDM ONLEIN(TM) CONTROLS
- K943999 — ABUSCREEN ONTRAK POSITIVE CONTROL
- K946000 — ABUSCREEN ONLINE(R) CALIBRATORS
- K945194 — ABUSCREEN ONLINE CONTROLS
- K945195 — ABUSCREEN ONLINE PROPOXPHENE
- K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
- K944231 — ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
- K941573 — ROCHE REAGENT
- K942048 — ROCHE AMMONIA (VARIOUS)
- K942114 — ROCHE TDM CALIBRATION VERIFICATION TEST SET
- K941837 — ROCHE REAGENT FOR CREATININE
- K935055 — ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
- K941440 — COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
- K941712 — COBAS-FP REAGENTS AND CALIBRATORS
- K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
- K936131 — COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
- K930844 — ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
- K935042 — ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
- K932605 — COBAS (R) CORE T4 EIA
- K932607 — COBAS(R) CORE FT4 EIA
- K935550 — ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
- K932548 — ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
- K930776 — COBAS CORE TSH EIA
- K932608 — COBAS(R) CORE T3 EIA
- K930928 — ROCHE ABUSCREEN ONLINE FOR METHADONE
- K930304 — COBAS CORE FSH EIA
- K933052 — ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
- K933053 — ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
- K932549 — ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
- K930305 — COBAS CORE PROLACTIN EIA
- K933279 — ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
- K930890 — COBAS(R) CORE IGE TOTAL EIA
- K931124 — ABUSCREEN ONLINE(R) CALIBRATORS
- K931125 — ABUSCREEN ONLINE CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.