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
1993–2016 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 07, 2008
PROLYTE ELECTROLYTE ANALYZER
K070104 · JGS
Diamond Diagnostics, Inc.
Chemistry · 483d
Cleared Apr 24, 2008
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 120d
Cleared Apr 21, 2008
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
K080501 · NBW
Taidoc Technology Corporation
Chemistry · 56d
Cleared Apr 18, 2008
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
K073231 · NBW
Lifescan, Inc.
Chemistry · 155d
Cleared Apr 18, 2008
3TEST SUPREME GLUCOSE MONITORING SYSTEM
K072905 · NBW
Neuero Engineering, Inc.
Chemistry · 190d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · LCP
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · CGS
Teco Diagnostics
Chemistry · 221d
Cleared Apr 14, 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · LBS
Medica Corp.
Chemistry · 123d
Cleared Apr 14, 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889 · CGZ
Wallac OY
Chemistry · 381d
Cleared Apr 10, 2008
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
K073648 · CGA
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Apr 10, 2008
GBI TSH NEONATAL SCREENING KIT
K072458 · JLW
Golden Bridge International, Inc.
Chemistry · 223d
Cleared Apr 08, 2008
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD...
K073492 · NBW
Tyson Bioresearch, Inc.
Chemistry · 118d
Cleared Apr 04, 2008
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
K063437 · JLW
Monobind, Inc.
Chemistry · 507d
Cleared Apr 02, 2008
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND...
K073494 · NBW
Taidoc Technology Corporation
Chemistry · 112d
Cleared Apr 01, 2008
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
K073137 · NBW
Apex BioTechnology Corp.
Chemistry · 146d
Cleared Mar 26, 2008
MCT-DIABETES
K073699 · NBW
Mycare Team, Inc.
Chemistry · 86d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET...
K080183 · DIF
Roche Diagnostics Corp.
Chemistry · 60d
Cleared Mar 25, 2008
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
K072441 · NBW
Tyson Bioresearch, Inc.
Chemistry · 208d
Cleared Mar 21, 2008
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
K072369 · NBW
Hmd Biomedical, LLC
Chemistry · 211d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · JIT
Beckman Coulter, Inc.
Chemistry · 56d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Abbott Laboratories
Chemistry · 289d
Cleared Mar 17, 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · LCP
Axis-Shield Diagnostics, Ltd.
Chemistry · 175d
Cleared Mar 14, 2008
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
K073265 · MXA
Apieron, Inc.
Chemistry · 115d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT...
K073604 · CEC
Dade Behring, Inc.
Chemistry · 83d