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
2233–2256 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Oct 23, 2006
INNOVACON HCG UKTRA TEST DEVICE
K062361 · JHI
Innovacon, Inc.
Chemistry · 70d
Cleared Oct 18, 2006
AMNIOSTAT-FLM-PG
K061549 · JHG
Irvine Scientific Sales Co., Inc.
Chemistry · 135d
Cleared Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K062668 · JJY
Aalto Scientific, Ltd.
Chemistry · 38d
Cleared Oct 16, 2006
ABL8X7 FLEX
K051968 · CGL
Radiometer Medical Aps
Chemistry · 453d