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
1465–1488 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 01, 2011
POLY-CHEM 90 TOTAL BILIRUBIN
K111143 · CIG
Polymedco, Inc.
Chemistry · 132d
Cleared Aug 31, 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G,...
K103747 · LBS
Elitechgroup Seppim S.A.S.
Chemistry · 251d
Cleared Aug 31, 2011
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE...
K101635 · NBW
Taidoc Technology Corporation
Chemistry · 447d
Cleared Aug 31, 2011
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL...
K101204 · CGA
Apex BioTechnology Corp.
Chemistry · 488d
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 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