Roche Diagnostic Systems, Inc.
Roche Diagnostic Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 1999.
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.