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
817–840 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 13, 2015
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K151642 · JXM
Healgen Scientific, LLC
Chemistry · 56d
Cleared Aug 07, 2015
Assure Prism multi Blood Glucose Monitoring System
K151164 · NBW
I-Sens, Inc.
Chemistry · 98d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
K150022 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 213d
Cleared Aug 06, 2015
ABL80 FLEX CO-OX with AQURE connectivity
K151856 · CHL
Sendx Medical, Inc.
Chemistry · 29d
Cleared Aug 06, 2015
Triglycerides
K150819 · CDT
Randox Laboratories Limited
Chemistry · 132d
Cleared Aug 06, 2015
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring...
K142689 · CGA
Apex BioTechnology Corp.
Chemistry · 318d
Cleared Aug 05, 2015
SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD...
K132929 · NBW
Sd Biosensor, Inc.
Chemistry · 687d
Cleared Jul 31, 2015
OneTouch Verio Flex Blood Glucose Monitoring System
K150214 · NBW
Lifescan Europe
Chemistry · 182d
Cleared Jul 24, 2015
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
K141289 · JIL
Teco Diagnostics
Chemistry · 431d
Cleared Jul 22, 2015
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · CJY
Elitechgroup
Chemistry · 86d
Cleared Jul 17, 2015
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA...
K143687 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 205d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · JIT
Abbott Laboratories
Chemistry · 30d
Cleared Jul 08, 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I,...
K151552 · JIX
Elitechgroup
Chemistry · 29d
Cleared Jul 07, 2015
CardioChek Plus Test System
K151530 · CGA
Polymer Technology Systems, Inc.
Chemistry · 29d
Cleared Jul 02, 2015
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
K143075 · CDZ
Tosoh Bioscience, Inc.
Chemistry · 248d
Cleared Jun 29, 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
K151441 · DJR
W.H.P.M., Inc.
Chemistry · 31d
Cleared Jun 22, 2015
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH...
K150879 · CEW
DiaSorin, Inc.
Chemistry · 82d
Cleared Jun 17, 2015
ABL800 FLEX with AQURE connectivity
K142898 · CHL
Radiometer Medical Aps
Chemistry · 254d
Cleared Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista...
K140790 · JIX
Siemens Healthcare Diagnostics
Chemistry · 441d
Cleared Jun 09, 2015
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose...
K141292 · NBW
Bionime Coporation
Chemistry · 386d
Cleared Jun 08, 2015
VIDAS FT4
K132058 · CEC
Biomerieux S.A.
Chemistry · 705d
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · NBW
Abbott Laboratories
Chemistry · 95d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · NBW
Abbott Laboratories
Chemistry · 115d
Cleared Jun 04, 2015
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31,...
K142595 · PDJ
Ortho-Clinical Diagnostics
Chemistry · 262d