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
1489–1512 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 30, 2011
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I,...
K112029 · JIX
Elitechgroup
Chemistry · 46d
Cleared Aug 30, 2011
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
K101543 · NBW
Tyson Bioresearch, Inc.
Chemistry · 453d
Cleared Aug 29, 2011
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
K110648 · CHL
Nova Biomedical Corporation
Chemistry · 178d
Cleared Aug 26, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI...
K102678 · NBW
Andon Medical Co., Ltd.
Chemistry · 344d
Cleared Aug 25, 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
K112104 · JJX
Roche Diagnostics
Chemistry · 34d
Cleared Aug 25, 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · LCP
Siemens Healthcare Diagnostics
Chemistry · 143d
Cleared Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K111952 · JIT
Beckman Coulter, Inc.
Chemistry · 39d
Cleared Aug 19, 2011
CKMB UDR ASSAY
K102706 · JHS
SENTINEL CH. SpA
Chemistry · 333d
Cleared Aug 17, 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · KHP
Nova Biomedical Corp.
Chemistry · 532d
Cleared Aug 16, 2011
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND...
K101973 · LAF
Omega Laboratories, Inc.
Chemistry · 399d
Cleared Aug 15, 2011
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · MQM
Siemens Healthcare Diagnostics
Chemistry · 196d
Cleared Aug 10, 2011
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N...
K110137 · JFY
HORIBA ABX SAS
Chemistry · 204d
Cleared Aug 09, 2011
CYBOW READER, MODELS 300 & 720
K102188 · KQO
DFI Co., Ltd.
Chemistry · 371d
Cleared CT Aug 09, 2011
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
K101307 · NBW
Andon Medical Co., Ltd.
Chemistry · 456d
Cleared Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
K111762 · JIT
Tosoh Bioscience, Inc.
Chemistry · 43d
Cleared Aug 03, 2011
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
K102760 · LCX
Atlas Medical
Chemistry · 314d
Cleared Jul 28, 2011
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS,...
K110571 · NBW
Telcare, Inc.
Chemistry · 149d
Cleared Jul 28, 2011
PREGNANCY ONE STEP RAPID TEST
K103574 · LCX
Lehnus & Associates Consulting
Chemistry · 234d
Cleared Jul 21, 2011
ELECSYS T3 CALCHECK 5
K111552 · JJX
Roche Diagnostics
Chemistry · 48d
Cleared Jul 20, 2011
AVIE A1C TEST SYSTEM
K093548 · LCP
Mec Dynamics Corp
Chemistry · 610d
Cleared Jul 19, 2011
ABL90
K111897 · CHL
Radiometer Medical Aps
Chemistry · 14d
Cleared Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO...
K111560 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 42d
Cleared Jul 15, 2011
OPIATE ENZYME IMMUNOASSAY
K110298 · DJG
Lin-Zhi International, Inc.
Chemistry · 164d
Cleared Jul 15, 2011
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
K102643 · KQP
Astoria-Pacific, Inc.
Chemistry · 304d