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."
73–96 of 264
Cleared Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
K051687 · JJY
Roche Diagnostics Corp.
Chemistry · 32d
Cleared Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
K051185 · JJY
Roche Diagnostics Corp.
Immunology · 58d
Cleared Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
K050231 · JIT
Roche Diagnostics Corp.
Immunology · 161d
Cleared Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
K051517 · JJY
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
K051292 · CGN
Roche Diagnostics Corp.
Chemistry · 30d
Cleared May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
K050872 · LFR
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
K043474 · LFR
Roche Diagnostics Corp.
Chemistry · 132d
Cleared Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
K050387 · JJY
Roche Diagnostics Corp.
Immunology · 69d
Cleared Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529 · NDC
Roche Diagnostics Corp.
General Hospital · 108d
Cleared Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
K043303 · JXN
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Feb 08, 2005
TINA-QUANT IGG GEN.2
K050113 · DEW
Roche Diagnostics Corp.
Immunology · 21d
Cleared Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
K043327 · JXM
Roche Diagnostics Corp.
Toxicology · 67d
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