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"
265–288 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · LEH
Roche Diagnostics Corp.
Toxicology · 65d
Cleared May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · CKG
Roche Diagnostics Corp.
Chemistry · 57d
Cleared Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
K060754 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 10, 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · CDD
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Mar 15, 2006
TDM CONTROL SET
K060429 · JJY
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Mar 13, 2006
COBAS 6000 SERIES SYSTEM
K060373 · CEM
Roche Diagnostics
Immunology · 28d
Cleared Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108 · CGZ
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA...
K053603 · NQD
Roche Diagnostics Corp.
Chemistry · 48d
Cleared Feb 07, 2006
ROCHE ELECSYS ANTI-TG
K053426 · JZO
Roche Diagnostics Corp.
Immunology · 61d
Cleared Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · JGS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
K051382 · NBC
Roche Diagnostics Corp.
Chemistry · 192d
Cleared Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
K053059 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
K052982 · JIT
Roche Diagnostics
Chemistry · 4d
Cleared Oct 17, 2005
ELECSYS PRECICONTROL BONE
K051543 · JJY
Roche Diagnostics Corp.
Chemistry · 129d
Cleared Oct 03, 2005
ISE COMPENSATOR
K052193 · JIT
Roche Diagnostics
Chemistry · 53d
Cleared Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464 · LCP
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760 · LZG
Roche Diagnostics Corp.
General Hospital · 173d
Cleared Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN...
K051297 · NEO
Roche Diagnostics Corp.
Chemistry · 113d
Cleared Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592 · LFR
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
K052101 · KRZ
Roche Diagnostics
Chemistry · 23d
Cleared Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,...
K051376 · CHH
Roche Diagnostics
Chemistry · 89d
Cleared Aug 22, 2005
IRON STANDARD
K052002 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · JZO
Roche Diagnostics Corp.
Immunology · 23d
Cleared Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
K051687 · JJY
Roche Diagnostics Corp.
Chemistry · 32d