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
1729–1752 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · CEM
Abbott Laboratories
Chemistry · 119d
Cleared Feb 18, 2010
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
K093635 · NBW
Taidoc Technology Corporation
Chemistry · 87d
Cleared Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · CDD
Siemens Healthcare Diagnostics
Chemistry · 80d
Cleared Feb 05, 2010
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING...
K093005 · NBW
Taidoc Technology Corporation
Chemistry · 130d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS...
K092649 · NBC
Roche Diagnostics Corp.
Chemistry · 160d
Cleared Feb 04, 2010
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
K090609 · NBW
Ok Biotech Co., Ltd.
Chemistry · 335d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764 · DKZ
Roche Diagnostics Corp.
Chemistry · 412d
Cleared Jan 19, 2010
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
K091765 · NBW
Visgeneer, Inc.
Chemistry · 216d
Cleared Jan 15, 2010
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS...
K091547 · NBW
Nova Biomedical Corp.
Chemistry · 233d
Cleared Jan 14, 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...
K091867 · CDZ
Siemens Healthcare Diagnostics
Chemistry · 205d
Cleared Jan 14, 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL...
K082275 · LCP
Infopia Co, Ltd.
Chemistry · 521d
Cleared Dec 24, 2009
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
K093035 · NBW
Taidoc Technology Corporation
Chemistry · 85d
Cleared Dec 23, 2009
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
K093098 · KQO
Arkray, Inc.
Chemistry · 83d
Cleared Dec 16, 2009
ELECSYS PROBNP II CALCHECK 5
K092169 · JJX
Roche Diagnostics
Chemistry · 148d
Cleared Dec 14, 2009
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
K093498 · JJX
DiaSorin, Inc.
Chemistry · 32d
Cleared Dec 14, 2009
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
K090940 · JJT
Astoria-Pacific, Inc.
Chemistry · 255d
Cleared Dec 11, 2009
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 184d
Cleared Dec 10, 2009
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253...
K092099 · NBW
Taidoc Technology Corporation
Chemistry · 149d
Cleared Dec 08, 2009
SD CHECK GOLD
K082683 · NBW
Standard Diagnostics, Inc.
Chemistry · 449d
Cleared Dec 07, 2009
DS-A BLOOD GLUCOSE MONITORING SYSTEM
K082965 · CGA
Alliance International Co., Ltd.
Chemistry · 430d
Cleared Dec 04, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K093458 · JFY
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · CFR
Roche Diagnostics
Chemistry · 101d
Cleared CT Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
K090628 · NBW
Bayer Healthcare, LLC
Chemistry · 270d
Cleared Dec 01, 2009
LIPIDPRO SYSTEM
K090405 · NBW
Infopia Co, Ltd.
Chemistry · 285d