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
1849–1872 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 06, 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · JGS
Diamond Diagnostics, Inc.
Chemistry · 163d
Cleared Feb 03, 2009
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
K083265 · NBW
Agamatrix, Inc.
Chemistry · 90d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 80d
Cleared Jan 30, 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · DCN
Alfa Wassermann Diagnostic...
Chemistry · 108d
Cleared Jan 30, 2009
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM,...
K082482 · CGA
Taidoc Technology Corporation
Chemistry · 155d
Cleared Jan 27, 2009
APIERON INSIGHT ENO SYSTEM
K083617 · MXA
Apieron, Inc.
Chemistry · 50d
Cleared Jan 23, 2009
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
K081796 · NBW
Eps Bio Technology Corp.
Chemistry · 212d
Cleared Jan 16, 2009
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
K083099 · NBW
Eps Bio Technology Corp.
Chemistry · 88d
Cleared Jan 16, 2009
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
K082521 · NBW
Card Guard Scientific Survival , Ltd.
Chemistry · 136d
Cleared Jan 16, 2009
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · JJW
Cliniqa Corporation
Chemistry · 197d
Cleared Jan 16, 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · CIG
Roche Diagnostics
Chemistry · 263d
Cleared Jan 13, 2009
DIAZYME LP(A) ASSAY
K082488 · DFC
General Atomics
Chemistry · 138d
Cleared Jan 09, 2009
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
K083664 · CGA
Taidoc Technology Corporation
Chemistry · 30d
Cleared Jan 09, 2009
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
K081767 · NQM
Amnisure International, LLC
Chemistry · 203d
Cleared Jan 08, 2009
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
K081895 · LCP
Siemens Medical Solutions Diagnostics
Chemistry · 189d
Cleared Jan 08, 2009
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
K081703 · NBW
Entra Health Systems, Ltd.
Chemistry · 205d
Cleared Dec 24, 2008
ENVISION BLOOD GLUCOSE TEST SYSTEM
K082020 · NBW
Infopia Co, Ltd.
Chemistry · 161d
Cleared Dec 22, 2008
ABT GLUCOSE CONTROL SOLUTION
K083549 · JJX
American Biological Technologies, Inc.
Chemistry · 21d
Cleared Dec 22, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS...
K083173 · JLW
Ortho-Clinical Diagnostics
Chemistry · 56d
Cleared Dec 17, 2008
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
K081715 · NBW
Taidoc Technology Corporation
Chemistry · 182d
Cleared Dec 16, 2008
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
K082210 · CIG
Genzyme Diagnostics P.E.I., Inc.
Chemistry · 132d
Cleared Dec 16, 2008
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
K081929 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 162d
Cleared Dec 10, 2008
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND...
K080810 · CIG
Medica Corp.
Chemistry · 264d
Cleared Dec 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE,...
K071474 · NTV
Siemens Healthcare Diagnostics
Chemistry · 561d