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"
145–168 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Oct 18, 2011
ELECSYS T4 CALCHECK 5
K112528 · JJX
Roche Diagnostics Corporation
Chemistry · 48d
Cleared Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299 · LFR
Roche Diagnostics
Chemistry · 499d
Cleared Sep 14, 2011
ELECSYS MYOGLOBIN CALCHECK 5
K112113 · JJX
Roche Diagnostics
Chemistry · 51d
Cleared Aug 25, 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
K112104 · JJX
Roche Diagnostics
Chemistry · 34d
Cleared Jul 21, 2011
ELECSYS T3 CALCHECK 5
K111552 · JJX
Roche Diagnostics
Chemistry · 48d
Cleared Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
K111506 · JJY
Roche Diagnostics
Chemistry · 37d
Cleared Jun 09, 2011
ELECSYS SHBG CALCHECK 5
K111349 · JJX
Roche Diagnostics
Chemistry · 27d
Cleared May 12, 2011
ELECSYS PROLACTIN II CALCHECK 5
K110613 · JJX
Roche Diagnostics
Chemistry · 70d
Cleared May 12, 2011
ROCHE ELECSYS FOLATE RBC
K103716 · CGN
Roche Diagnostics
Chemistry · 142d
Cleared May 03, 2011
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL...
K110446 · DKZ
Roche Diagnostics
Toxicology · 76d
Cleared Feb 25, 2011
ROCHE FLUDI METHAMPHETAMINE
K093884 · LAF
Roche Diagnostics
Toxicology · 434d
Cleared Feb 11, 2011
ELECSYS ANTI-TPO CALSET
K103171 · JIX
Roche Diagnostics
Immunology · 107d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160 · DIO
Roche Diagnostics
Chemistry · 291d
Cleared Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
K093867 · DJG
Roche Diagnostics
Chemistry · 402d
Cleared Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
K093989 · LCM
Roche Diagnostics
Chemistry · 397d
Cleared Jan 20, 2011
ELECYSYS SHBG
K102814 · CDZ
Roche Diagnostics
Chemistry · 114d
Cleared Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
K103402 · JJX
Roche Diagnostics
Chemistry · 49d
Cleared Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
K103221 · JIT
Roche Diagnostics
Chemistry · 52d
Cleared Dec 06, 2010
PRECICONTROL HBA1C NORM
K103099 · JJX
Roche Diagnostics
Chemistry · 47d
Cleared Nov 18, 2010
ELECSYS PTH CALCHECK 5
K103162 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
K102086 · JJX
Roche Diagnostics
Immunology · 98d
Cleared Oct 07, 2010
ELECSYS IGE CALCHECK 5
K102269 · JJX
Roche Diagnostics
Immunology · 59d
Cleared Oct 05, 2010
ELECSYS CEA CALCHECK 5
K101856 · JJX
Roche Diagnostics
Immunology · 96d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365 · JJX
Roche Diagnostics Corp.
Immunology · 141d