FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
2521–2544 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
K051087 · JJE
Dade Behring, Inc.
Chemistry · 74d
Cleared Jul 11, 2005
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
K050960 · JLX
Wallac OY
Chemistry · 84d
Cleared Jul 08, 2005
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
K051108 · CFJ
Abaxis, Inc.
Chemistry · 67d
Cleared Jul 06, 2005
1,25-DIHYDROXY VITAMIN D EIA
K051110 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 65d
Cleared Jul 06, 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
K042725 · DJG
Quest Diagnostics, Inc.
Chemistry · 278d
Cleared Jul 06, 2005
JAUNDICE METER, MODEL JM 103
K042522 · MQM
Draeger Medical Infant Care, Inc.
Chemistry · 293d
Cleared Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
K051517 · JJY
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jul 05, 2005
DCL MICROALBUMIN ASSAY, MODEL 252-20
K051191 · DCF
Diagnostic Chemicals , Ltd.
Chemistry · 56d
Cleared Jun 30, 2005
CREATININE LIQUICOLOR
K050283 · JFY
Stanbio Laboratory
Chemistry · 143d
Cleared Jun 30, 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266 · JFM
Stanbio Laboratory
Chemistry · 146d
Cleared Jun 28, 2005
HBA1C ENZYMATIC ASSAY
K050178 · LCP
General Atomics
Chemistry · 153d
Cleared Jun 27, 2005
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
K050500 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 119d
Cleared Jun 24, 2005
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K051088 · DKB
Lin-Zhi International, Inc.
Chemistry · 57d
Cleared Jun 17, 2005
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
K051432 · CIG
Arkray, Inc.
Chemistry · 16d
Cleared Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
K051292 · CGN
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Jun 15, 2005
DIADEXUS PLAC TEST
K050523 · NOE
Diadexus, Inc.
Chemistry · 105d
Cleared Jun 15, 2005
ADVIA IMS LITHIUM ASSAY
K050374 · NDW
Bayer Healthcare, LLC
Chemistry · 121d
Cleared Jun 13, 2005
INVIEW
K051321 · LCP
Metrika, Inc.
Chemistry · 24d
Cleared Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
K051307 · JXM
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 13, 2005
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K051265 · NBC
Bayer Healthcare, LLC
Chemistry · 28d
Cleared Jun 13, 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · DJG
Lin-Zhi International, Inc.
Chemistry · 88d
Cleared Jun 08, 2005
ON TRAK TESTCARD
K051235 · DKZ
Varian, Inc.
Chemistry · 26d
Cleared Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · LDJ
ACON Laboratories, Inc.
Chemistry · 63d
Cleared Jun 06, 2005
SPOTCHEM II LDH TEST
K050790 · CFH
Arkray, Inc.
Chemistry · 70d