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
2209–2232 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Dec 01, 2006
MISSION TRINITY B
K062674 · JJY
Diamond Diagnostics, Inc.
Chemistry · 84d
Cleared Nov 29, 2006
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K062581 · JLW
Olympus America, Inc.
Chemistry · 90d
Cleared Nov 22, 2006
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
K063212 · NBW
Taidoc Technology Corporation
Chemistry · 30d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Abbott Laboratories
Chemistry · 58d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE,...
K062637 · DJR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 78d
Cleared Nov 22, 2006
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
K062593 · JJY
Compass Bioscience
Chemistry · 82d
Cleared Nov 22, 2006
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20
K062467 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 90d
Cleared Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
K062347 · NBW
Bayer Healthcare, LLC
Chemistry · 104d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1,...
K062094 · LCM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 121d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · DKZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 124d
Cleared Nov 22, 2006
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
K061617 · DKZ
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 166d
Cleared Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062123 · DIO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d
Cleared Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144 · JJE
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 13, 2006
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
K062434 · NBW
Agamatrix
Chemistry · 84d
Cleared Nov 03, 2006
POLY-CHEM CREATININE
K061944 · JFY
Polymedco, Inc.
Chemistry · 116d
Cleared Nov 01, 2006
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · CIG
Nova Biomedical Corp.
Chemistry · 126d
Cleared Oct 30, 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI...
K063024 · DKZ
Lin-Zhi International, Inc.
Chemistry · 28d
Cleared Oct 30, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922 · DJZ
Sentech Korea Corp.
Chemistry · 115d
Cleared Oct 30, 2006
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
K061234 · NBW
Glucoplus, Inc.
Chemistry · 181d
Cleared Oct 23, 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
K062916 · JJY
Cliniqa Corporation
Chemistry · 25d