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
2209–2232 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 17, 2007
COBAS INTEGRA C 111
K063744 · CIG
Rochdiag
Chemistry · 30d
Cleared Jan 12, 2007
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
K063409 · NBW
Agamatrix
Chemistry · 60d
Cleared Jan 12, 2007
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
K062966 · ORH
Seradyn, Inc.
Chemistry · 105d
Cleared Jan 12, 2007
CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/...
K062800 · NBW
Taidoc Technology Corporation
Chemistry · 115d
Cleared Jan 12, 2007
EASYGLUCO, MODEL IGM-0002 G2
K061431 · CGA
U. S. Diagnostics, Inc.
Chemistry · 233d
Cleared Jan 05, 2007
VITROS CHEMISTRY PRODUCTS BARB REAGENT
K062165 · DIS
Ortho-Clinical Diagnostics
Chemistry · 161d
Cleared Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276 · JIL
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · LPS
Dade Behring, Inc.
Chemistry · 66d
Cleared Dec 27, 2006
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT...
K063643 · LCP
Bio-Rad Laboratories Inc., Clinical...
Chemistry · 20d
Cleared Dec 27, 2006
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
K062555 · NBW
Visgeneer, Inc.
Chemistry · 119d
Cleared Dec 26, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
K062924 · NQD
Dade Behring, Inc.
Chemistry · 89d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS...
K063543 · CIG
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Dec 22, 2006
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
K063224 · NZB
Gentris Corporation
Chemistry · 59d
Cleared Dec 22, 2006
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
K063057 · NQD
Diagnostic Products Corporation
Chemistry · 78d
Cleared Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062285 · JXM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 137d
Cleared Dec 20, 2006
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
K063068 · NBW
Arkray USA, Inc.
Chemistry · 75d
Cleared Dec 20, 2006
CORTISOL ELISA
K062626 · CGR
Ibl-Hamburg GmbH
Chemistry · 106d
Cleared Dec 19, 2006
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE...
K062838 · MMI
Ortho-Clinical Diagnostics
Chemistry · 89d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY...
K063591 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE...
K062460 · DJG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d
Cleared Dec 15, 2006
SDI CA480 CLINICAL CHEMISTRY SYSTEM
K061879 · CFR
Hemodiagnostica, LLC
Chemistry · 165d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Dec 05, 2006
URITEST 10 URINALYSIS REAGENT STRIPS
K052719 · CDM
Arj Medical, Inc.
Chemistry · 432d
Cleared Dec 01, 2006
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 22d