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

Filters: Chemistry ×
13,257 results
1681–1704 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Apr 08, 2010
DIAZYME CYSTATIN C ASSAY
K093680 · NDY
Diazyme Laboratories
Chemistry · 132d
Cleared Apr 07, 2010
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441 · KXT
Siemens Healthcare Diagnostics
Chemistry · 153d
Cleared Apr 06, 2010
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · JGS
Medica Corp.
Chemistry · 28d
Cleared Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555 · KQO
Roche Diagnostics
Chemistry · 136d