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"
121–144 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · LFR
Roche Diagnostics Operations, Inc.
Chemistry · 151d
Cleared Aug 09, 2013
ACCU-CHEK AVIVA PLUS TEST STRIP
K131029 · NBW
Roche Diagnostics Operations, Inc.
Chemistry · 119d
Cleared Aug 08, 2013
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
K121610 · PDJ
Roche Diagnostics Operations
Chemistry · 433d
Cleared Jul 17, 2013
COBAS C BILIRUBIN TOTAL GEN.3
K131544 · CIG
Roche Diagnostics
Chemistry · 49d
Not Cleared May 23, 2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
DEN130002 · PDJ
Roche Diagnostics
Chemistry · 59d
Cleared May 21, 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
K123726 · JGS
Roche Diagnostics
Chemistry · 168d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · NBW
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
K123965 · CIG
Roche Diagnostics
Chemistry · 64d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · NBW
Roche Diagnostics
Chemistry · 434d
Cleared Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
K122242 · JJX
Roche Diagnostics
Immunology · 131d
Cleared Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · DFC
Roche Diagnostics
Chemistry · 85d
Cleared Oct 11, 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · NBW
Roche Diagnostics
Chemistry · 126d
Cleared Sep 10, 2012
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4...
K112624 · OIU
Roche Diagnostics
Immunology · 368d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · JJX
Roche Diagnostics
Microbiology · 56d
Cleared Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · MXJ
Roche Diagnostics
Microbiology · 146d
Cleared Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3...
K113546 · MRG
Roche Diagnostics
Chemistry · 236d
Cleared Jul 17, 2012
ACCU-CHECK COMBO SYSTEM
K111353 · LZG
Roche Diagnostics
General Hospital · 428d
Cleared May 14, 2012
TINA-QUANT ALBUMIN GEN.2
K113072 · DCF
Roche Diagnostics Operations
Toxicology · 210d
Cleared May 14, 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123...
K111188 · CHL
Roche Diagnostics
Chemistry · 383d
Cleared May 10, 2012
ELECSYS LH CALCHECK 5
K121279 · JJX
Roche Diagnostics
Chemistry · 10d
Cleared May 08, 2012
CALCIUM GEN. 2
K113521 · CHW
Roche Diagnostics
Chemistry · 161d
Cleared Jan 06, 2012
GLUCOSE TEST SYSTEM
K113137 · NBW
Roche Diagnostics
Chemistry · 74d
Cleared Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
K110726 · LDP
Roche Diagnostics
Chemistry · 282d
Cleared Dec 23, 2011
TINA-QUANT HBA1C GEN.2
K110313 · LCP
Roche Diagnostics
Chemistry · 324d