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
2185–2208 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 12, 2007
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
K063647 · NDY
Thermo Electron OY
Chemistry · 95d
Cleared Mar 06, 2007
VAP-NT CHOLESTEROL TEST
K062026 · CHH
Atherotech, Inc.
Chemistry · 231d
Cleared Mar 01, 2007
URINE CHEMISTRY ANALYZER UR-50
K063390 · JIL
Ind Diagnostic, Inc.
Chemistry · 112d
Cleared Feb 23, 2007
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR,...
K063754 · DHA
Dade Behring, Inc.
Chemistry · 66d
Cleared Feb 23, 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1...
K063608 · MSJ
Dade Behring, Inc.
Chemistry · 81d
Cleared Feb 23, 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · JFY
Wako Chemicals USA, Inc.
Chemistry · 245d
Cleared Feb 20, 2007
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
K062565 · MKU
Princeton BioMeditech Corp.
Chemistry · 173d
Cleared Feb 16, 2007
ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
K070088 · NBW
Apex BioTechnology Corp.
Chemistry · 38d
Cleared Feb 16, 2007
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K062567 · NBW
Bionime Corporation
Chemistry · 169d
Cleared Feb 09, 2007
OK METER BLOOD GLUCOSE MONITORING SYSTEM
K063026 · NBW
Ok Biotech Co., Ltd.
Chemistry · 130d
Cleared Feb 06, 2007
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
K062799 · CGA
Apex BioTechnology Corp.
Chemistry · 140d
Cleared Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144 · JIT
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Feb 01, 2007
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL...
K063855 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 35d
Cleared Jan 31, 2007
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
K070017 · NBW
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · JJY
Roche Diagnostics Corp.
Chemistry · 169d
Cleared Jan 26, 2007
TECO MICROALBUMIN 2-1 COMBO STRIPS
K061419 · JIR
Teco Diagnostics
Chemistry · 249d
Cleared Jan 25, 2007
ACTIM PROM AND CONTROLS
K061886 · OAM
Medix Biochemica
Chemistry · 206d
Cleared Jan 24, 2007
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K063821 · CGA
Nova Biomedical Corp.
Chemistry · 29d
Cleared Jan 23, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508 · JIX
Dade Behring, Inc.
Chemistry · 64d
Cleared Jan 23, 2007
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG...
K060818 · CDZ
Biokit, S.A.
Chemistry · 302d
Cleared Jan 22, 2007
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND...
K063351 · NDY
Dade Behring, Inc.
Chemistry · 77d
Cleared Jan 22, 2007
EUKARE
K062892 · CGA
Eumed Biotechnology Co., Ltd.
Chemistry · 118d
Cleared Jan 19, 2007
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K063208 · JGJ
Diagnostic Chemicals , Ltd.
Chemistry · 88d
Cleared Jan 19, 2007
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
K062503 · KWW
Catachem, Inc.
Chemistry · 147d