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
1225–1248 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
K123966 · JJX
Bionostics, Inc.
Chemistry · 30d
Cleared Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE...
K123008 · NBW
Bionime Corporation
Chemistry · 120d
Cleared Jan 25, 2013
LIAISON TESTOSTERONE
K122793 · CDZ
DiaSorin, Inc.
Chemistry · 135d
Cleared Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
K123612 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 55d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372 · JIX
Abbott Laboratories
Chemistry · 74d
Cleared Jan 14, 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
K121706 · CGA
Foracare, Inc.
Chemistry · 220d
Cleared Jan 10, 2013
BLOOD CULTURE HOLDER
K122687 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 128d
Cleared Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
K123798 · JJX
Bio-Rad Laboratories
Chemistry · 30d
Cleared Jan 01, 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K121944 · CIB
DiaSorin, Inc.
Chemistry · 182d
Cleared Dec 27, 2012
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
K123683 · MXA
Aerocrine AB
Chemistry · 27d
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Dec 27, 2012
QUICK SAMPLER HOLDER
K120490 · JKA
Nipro Medical Corporation
Chemistry · 314d
Cleared Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST...
K122961 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 87d
Cleared Dec 21, 2012
GLOOKO LOGBOOK CHARTS
K122142 · NBW
Glooko, Inc.
Chemistry · 155d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · DFC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
K122435 · LFR
Nova Biomedical Corporation
Chemistry · 132d
Cleared Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
K121027 · JIT
Diamond Diagnostics, Inc.
Chemistry · 260d
Cleared Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · NBW
ACON Laboratories, Inc.
Chemistry · 78d
Cleared Dec 12, 2012
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
K121842 · LCP
Axis-Shield Diagnostics, Ltd.
Chemistry · 170d
Cleared Dec 11, 2012
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K120866 · NBW
Delbio Incorporation
Chemistry · 264d
Cleared Dec 07, 2012
BLOOD GLUCOSE MONITORING SYSTEM
K120813 · NBW
Andon Medical Co., Ltd.
Chemistry · 263d
Cleared Dec 06, 2012
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C...
K122101 · LCP
Sebia
Chemistry · 143d
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA...
K121994 · CDD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 147d
Cleared Nov 30, 2012
GENSTRIP TEST STRIP MODEL 100-201
K103542 · NBW
Shasta Technologies, LLC
Chemistry · 729d