Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

264 results for "Roche Diagnostics Corp."
97–120 of 264
Cleared May 17, 2004
ELECSYS TROPONIN T STAT TEST
K040733 · MMI
Roche Diagnostics Corp.
Chemistry · 56d
Cleared May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · MQM
Roche Diagnostics Corp.
Chemistry · 109d
Cleared Apr 22, 2004
ACCU-CHEK GO SYSTEM
K040796 · LFR
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264 · JIX
Roche Diagnostics Corp.
Chemistry · 58d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · JIX
Roche Diagnostics Corp.
Chemistry · 50d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280 · JJY
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · CZP
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · DEW
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · DAO
Roche Diagnostics Corp.
Immunology · 20d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157 · JJX
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · JIX
Roche Diagnostics Corp.
Toxicology · 60d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · KLR
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · LBZ
Roche Diagnostics Corp.
Toxicology · 167d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · JJY
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
K033612 · NPR
Roche Diagnostics Corp.
Pathology · 31d
Cleared Dec 17, 2003
LIGHTCYCLER INSTRUMENT VERSION 1.2
K033734 · JJF
Roche Diagnostics Corp.
Chemistry · 19d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · NPQ
Roche Diagnostics Corp.
Pathology · 9d
Cleared Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · DKB
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · LBS
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · DLJ
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · KHE
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · JIX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
K032646 · NBC
Roche Diagnostics Corp.
Chemistry · 77d
Cleared Oct 17, 2003
ROCHE DIAGNOSTICS OMNI S ANALYZER
K032311 · CEM
Roche Diagnostics Corp.
Chemistry · 81d