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
1657–1680 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 27, 2010
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
K091168 · NBW
Infopia Co, Ltd.
Chemistry · 400d
Cleared May 19, 2010
ADVIA CHEMISTRY SALICYLATE REAGENT
K093939 · DKJ
Siemens Healthcare Diagnostics
Chemistry · 148d
Cleared May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · LBS
Beckman Coulter, Inc.
Chemistry · 130d
Cleared May 14, 2010
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite...
K092602 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 262d
Cleared May 12, 2010
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
K100560 · NBW
Biotest Medical Corp.
Chemistry · 72d
Cleared May 12, 2010
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · DKZ
Microgenics Corp.
Chemistry · 223d
Cleared May 11, 2010
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
K100406 · CGA
Taidoc Technology Corporation
Chemistry · 84d
Cleared May 10, 2010
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF...
K100289 · KHS
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared May 05, 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
K100778 · JIX
Siemens Healthcare Diagnostics
Chemistry · 47d
Cleared May 05, 2010
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
K100187 · CGA
Medica Corp.
Chemistry · 103d
Cleared May 05, 2010
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B...
K094005 · NBW
Taidoc Technology Corporation
Chemistry · 128d
Cleared Apr 29, 2010
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
K091486 · DCF
Kamiya Biomedical Co.
Chemistry · 345d
Cleared Apr 27, 2010
ELECSYS FOLATE III CALCHECK 5
K094031 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Apr 27, 2010
URITEST 50 AND URITEST 500 URINE ANALYZER
K091472 · KQO
Arj Medical, Inc.
Chemistry · 344d
Cleared Apr 26, 2010
ELECSYS C-PEPTIDE CALCHECK 5
K100810 · JJX
Roche Diagnostics
Chemistry · 35d
Cleared Apr 26, 2010
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL...
K092911 · JJX
Diazyme Laboratories
Chemistry · 216d
Cleared Apr 23, 2010
ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
K093940 · NBW
Taidoc Technology Corporation
Chemistry · 122d
Cleared Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · CDZ
Roche Diagnostics Corp.
Chemistry · 171d
Cleared Apr 19, 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · DJR
Biosite Incorporated
Chemistry · 286d
Cleared Apr 15, 2010
ELECSYS TSH CALCHECK 5
K093836 · JJX
Roche Diagnostics
Chemistry · 121d
Cleared Apr 15, 2010
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES
K093611 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 143d
Cleared Apr 14, 2010
CONTREX PLUS LOW CONTROL SOLUTION
K100747 · JJX
Apex BioTechnology Corp.
Chemistry · 29d
Cleared Apr 14, 2010
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
K100108 · NGL
Amedica Biotech, Inc.
Chemistry · 90d
Cleared Apr 08, 2010
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
K100701 · NBW
Biotest Medical Corp.
Chemistry · 27d