FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
2161–2184 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 16, 2007
OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
K062521 · JIT
Thermo-Electron Corp.
Chemistry · 200d
Cleared Mar 15, 2007
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD...
K070472 · NBW
Taidoc Technology Corporation
Chemistry · 23d
Cleared Mar 13, 2007
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
K070223 · JJY
Aalto Scientific, Ltd.
Chemistry · 48d
Cleared Mar 13, 2007
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K060452 · JLX
Neo-Genesis
Chemistry · 385d
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