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
1873–1896 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Dec 04, 2008
PRO GLUCOSE TEST STRIP
K082169 · NBW
Taidoc Technology Corporation
Chemistry · 125d
Cleared Dec 04, 2008
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
K080485 · CIT
Diasys Diagnostics Systems GmbH
Chemistry · 286d
Cleared Nov 26, 2008
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01...
K081975 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 138d
Cleared Nov 19, 2008
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
K082714 · JJY
Aalto Scientific, Ltd.
Chemistry · 63d