Search FDA 510(k) Devices

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

479 results for "Roche Diagnostics"
289–312 of 479
Cleared Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
K043327 · JXM
Roche Diagnostics Corp.
Toxicology · 67d
Cleared Jan 31, 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
K050026 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · LCM
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Dec 29, 2004
ONLINE DAT BARBITURATES PLUS
K043211 · DIS
Roche Diagnostics Corp.
Toxicology · 40d
Cleared Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
K043318 · CGN
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
K043320 · JJX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
K043175 · NHG
Roche Diagnostics Corp.
Chemistry · 8d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · JIT
Roche Diagnostics Corp.
Immunology · 14d
Cleared Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH...
K042485 · NQD
Roche Diagnostics Corp.
Chemistry · 46d
Cleared Sep 30, 2004
ELECSYS FOLATE II CALSET II
K042490 · JIT
Roche Diagnostics Corp.
Chemistry · 16d
Cleared Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL...
K042389 · JJY
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
K033491 · DAP
Roche Diagnostics Corp.
Hematology · 302d
Cleared Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND...
K041812 · JJY
Roche Diagnostics Corp.
Chemistry · 21d
Cleared May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL...
K041227 · JJY
Roche Diagnostics Corp.
Chemistry · 17d
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