FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
721–744 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access...
K153651 · JLW
Beckman Coulter, Inc.
Chemistry · 241d
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators,...
K153375 · MRG
Abbott Laboratories
Chemistry · 263d
Cleared Aug 10, 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · JJX
Aalto Scientific, Ltd.
Chemistry · 33d
Cleared Aug 05, 2016
On Call Pro Blood Glucose Monitoring System
K161867 · NBW
Acon Laboratories
Chemistry · 29d
Cleared Jul 29, 2016
UniStrip1 Generic Blood Glucose Test Strips
K160038 · NBW
Ok Biotech Co., Ltd.
Chemistry · 204d
Cleared Jul 27, 2016
Tina-quant Cystatin C Gen.2
K161817 · NDY
Roche Diagnostics Operations (Rdo)
Chemistry · 26d
Cleared Jul 26, 2016
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur...
K160757 · CDD
Axis-Shield Diagnostics Limited
Chemistry · 130d
Cleared Jul 22, 2016
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K160372 · JIL
Teco Diagnostics, Inc.
Chemistry · 163d
Cleared Jul 20, 2016
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood...
K152599 · NBW
Ok Biotech Co., Ltd.
Chemistry · 313d
Cleared Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
K151978 · CHL
Edan Instruments, Inc.
Chemistry · 364d
Cleared Jul 08, 2016
i-STAT Alinity System with i-STAT Sodium test
K153357 · JGS
Abbott Point of Care, Inc.
Chemistry · 231d
Cleared Jun 29, 2016
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)...
K151986 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 348d
Cleared Jun 24, 2016
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next...
K160430 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 129d
Cleared Jun 24, 2016
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
K153692 · CGA
Infrared Laboratory Systems, LLC (Dba...
Chemistry · 184d
Cleared Jun 24, 2016
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor...
K153201 · NBW
Sd Biosensor
Chemistry · 233d
Cleared Jun 23, 2016
StatStrip Xpress Blood Glucose Monitoring System
K160156 · NBW
Nova Biomedical Corporation
Chemistry · 153d
Cleared Jun 09, 2016
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M...
K160370 · JGS
Shenzhen Mindray Bio-Medical...
Chemistry · 120d
Cleared Jun 01, 2016
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit,...
K153165 · PIG
Astute Medical, Inc.
Chemistry · 212d
Cleared May 31, 2016
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
K160647 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 85d
Cleared May 26, 2016
eSensor Warfarin Sensitivity Saliva Test
K152612 · ODW
Genmark Diagnostics, Incorporated
Chemistry · 255d
Cleared May 26, 2016
Oragene Dx
K152556 · OYJ
DNA Genotek, Inc.
Chemistry · 261d
Cleared May 26, 2016
ORAcollect.Dx
K152464 · OYJ
DNA Genotek, Inc.
Chemistry · 269d
Cleared May 25, 2016
Creatine Kinase
K160570 · JHS
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
K161140 · JIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d