Roche Diagnostics Corp.
Roche Diagnostics Corp. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2013.
Clearances by Roche Diagnostics Corp. — page 2
101–200 of 264- K040245 — CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
- K040280 — PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
- K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
- K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
- K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
- K040157 — ELECSYS C-PEPTIDE CALCHECK
- K033873 — ELECSYS C-PEPTIDE CALSET
- K032332 — ROCHE ONLINE TDM QUINIDINE
- K032334 — ROCHE ONLINE TDM LIDOCAINE
- K033937 — ELECSYS PRECICONTROL MULTIANALYTE
- K033612 — FACTOR II (PROTHROMBIN) G20210A KIT
- DEN030005 — FACTOR V LEIDEN KIT
- K033734 — LIGHTCYCLER INSTRUMENT VERSION 1.2
- K033306 — PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
- K033610 — HDL-CHOLESTEROL PLUS 2ND GENERATION
- K033246 — PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
- K033548 — ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
- K033501 — MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
- K032646 — ELECSYS PROBNP IMMUNOASSAY
- K032311 — ROCHE DIAGNOSTICS OMNI S ANALYZER
- K033009 — ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
- K033165 — PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
- K033185 — COBAS INTEGRA ALP IFCC GEN.2
- K032279 — ONLINE TDM AMIKA
- K032437 — CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
- K031902 — ONLINE TDM CARBAMAZEPINE
- K032552 — ACCU-CHEK ADVANTAGE SYSTEM
- K032535 — MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K032049 — ROCHE ONLINE TDM VALPROIC ACID
- K032377 — ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
- K031698 — ELECYS SHBG CALCHECK
- K031990 — ELECSYS PRECICONTROL TROPONIN T
- K031856 — PRECISET TDM I AND PRECISET TDM II CALIBRATORS
- K031717 — ELECSYS SHBG IMMUNOASSAY
- K031775 — PRECISET DAT PLUS I CALIBRATORS
- K032336 — TINA-QUANT CRP (LATEX)
- K032089 — ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
- K031650 — FERRITIN GENERATION 2
- K031879 — COBAS INTEGRA CARBON DIOXIDE ASSAY
- K031880 — AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
- K031824 — COBAS INTEGRA CHOLESTEROL GEN. 2
- K031755 — ACCU-CHEK COMPACT TEST STRIP
- K031756 — ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
- K030845 — COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
- K031299 — ELECSYS LH CALSET II
- K030428 — ROCHE ONLINE TDM PHENYTOIN
- K030213 — ONLINE DAT II CANNABINOIDS II
- K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
- K024098 — COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
- K023281 — ONLINE DAT II COCAINE II
- K020883 — ELECSYS PROBNP CALCHECK
- K023296 — COBAS INTEGRA ONLINE DAT II COCAINE II
- K022516 — ELECSYS PROBNP IMMUNOASSAY
- K021190 — PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
- K020831 — PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
- K021218 — ELECSYS CORTISOL TEST SYSTEM
- K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
- K020672 — ELECSYS ANTI-TG TEST SYSTEM
- K022171 — ACCU-CHEK COMPACT SYSTEM
- K021505 — ONLINE DAT II METHADONE II
- K021512 — COBAS INTEGRA ONLINE DAT II METHADONE II
- K020704 — ROCHE ONLINE GENTAMICIN
- K021827 — MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
- K021513 — ACCU-CHEK ADVANTAGE MODULE
- K021448 — MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
- K020740 — ROCHE ONLINE THEOPHYLLINE
- K014139 — DIABETES ASSISTANT SOFTWARE
- K020369 — ELECSYS ANTI-TG CALCHECK
- K013757 — ROCHE ACETAMINOPHEN
- K013482 — ABUSCREEN ONLINE OPIATES 300 / 2000
- K012324 — ACCU-CHEK ACTIVE TEST SYSTEM
- K011684 — INFLUENZA A/B RAPID TEST, CAT NO 2158 663
- K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM
- K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM
- K013206 — TINA-QUANT APOLIPOPROTEIN B VER.2
- K013249 — TINA-QUANT APOLIPOPROTEIN VER.2
- K013278 — TINA-QUANT APOLIPOPROTEIN A-1 VER.2
- K013207 — TINA-QUANT APOLIPOPROTEIN B VER.2
- K012396 — ONTRAK TESTCARD 9
- K013373 — OMNI C ANALYZER
- K012397 — URISYS 2400 URINE TEST STRIP
- K012371 — TINA-QUANT TRANSFERRIN VER.2
- K012393 — TINA-QUANT TRANSFERRIN VER.2
- K012399 — MODIFICATION TO ELECSYS FSH II CALSET
- K012210 — MODIFICATION TO ACCU-CHEK INFORM METER
- K012286 — MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
- K012287 — MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
- K011145 — MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
- K011226 — CALIBRATOR FOR AUTOMATED SYSTEMS
- K011738 — ACCU-CHEK ACTIVE SYSTEM
- K011143 — TINA-QUANT D-DIMER TEST SYSTEM
- K003400 — CRP HS TEST SYSTEM
- K003064 — TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
- K004010 — ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
- K010588 — ELECSYSCA 15-3 II ASSAY
- K003846 — ACCU-CHEK INFORM METER
- K002706 — ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
- K010362 — ACCU-CHEK COMFORT CURVE TEST STRIP
- K003411 — ELECSYS TESTOSTERONE CALSET II
- K003865 — COBAS INTEGRA AMPHETAMINES
Data sourced from openFDA. This site is unofficial and independent of the FDA.