Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

491 results for "Roche Diagnostics"
289–312 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Jul 11, 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · MMI
Roche Diagnostics
Chemistry · 12d
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 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
K050423 · CHL
Roche Diagnostics
Chemistry · 63d
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 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