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"
313–336 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
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
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