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
841–864 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 03, 2015
GE333 Blood Glucose Monitoring System
K143387 · NBW
Bionime Coporation
Chemistry · 189d
Cleared May 29, 2015
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE...
K141907 · CHL
Nova Biomedical Corporation
Chemistry · 318d
Cleared May 28, 2015
URISCAN OPTIMA
K141874 · KQO
Yd Diagnostics Corp.
Chemistry · 321d
Cleared May 26, 2015
Human Microalbumin kit for use on SPAPLUS
K143118 · DCF
The Binding Site Group , Ltd.
Chemistry · 208d