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"
241–264 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · JJY
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · GHH
Roche Diagnostics Corp.
Hematology · 225d
Cleared Feb 16, 2007
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
K063520 · OAV
Roche Diagnostics
Toxicology · 87d
Cleared Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · JJY
Roche Diagnostics Corp.
Chemistry · 169d
Cleared Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
K062114 · CHN
Roche Diagnostics Corp.
Immunology · 191d
Cleared Jan 29, 2007
COAGUCHEK XS PT CONTROLS
K063823 · GGN
Roche Diagnostics Corp.
Hematology · 34d
Cleared Jan 29, 2007
COAGUCHEK XS SYSTEM
K062925 · GJS
Roche Diagnostics Corp.
Hematology · 123d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS...
K063543 · CIG
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · JIX
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · CFR
Roche Diagnostics Corp.
Chemistry · 40d
Cleared Aug 31, 2006
ELECSYS IGE II IMMUNOASSAY
K061970 · JHR
Roche Diagnostics
Immunology · 50d
Cleared Aug 23, 2006
ONLINE TDM PROCAINAMIDE
K060773 · LAR
Roche Diagnostics Corp.
Toxicology · 154d
Cleared Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
K060738 · LAN
Roche Diagnostics Corp.
Toxicology · 149d
Cleared Aug 11, 2006
COAGUCHEK XS SYSTEM
K060978 · GJS
Roche Diagnostics
Hematology · 123d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · NBW
Roche Diagnostics Corp.
Chemistry · 156d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · LSL
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287 · MKZ
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Aug 08, 2006
ONLINE VALPROIC ACID
K060690 · LEG
Roche Diagnostics Corp.
Toxicology · 146d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · DDR
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Jul 03, 2006
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · DIH
Roche Diagnostics Corp.
Toxicology · 75d
Cleared Jun 09, 2006
ONLINE TDM TOBRAMYCIN
K060853 · KLB
Roche Diagnostics Corp.
Toxicology · 72d
Cleared May 30, 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS...
K060645 · DKB
Roche Diagnostics Corp.
Toxicology · 81d
Cleared May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · CFR
Roche Diagnostics Corp.
Chemistry · 30d