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
2329–2352 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · LCX
Unipath , Ltd.
Chemistry · 10d
Cleared Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND...
K060480 · CGR
Ortho-Clinical Diagnostics
Chemistry · 130d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · JIX
Dade Behring, Inc.
Chemistry · 60d
Cleared Jun 23, 2006
CREATININE
K061193 · CGX
Abbott Laboratories, Inc.
Chemistry · 56d
Cleared Jun 19, 2006
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825 · LCX
Mizuho USA, Inc.
Chemistry · 84d
Cleared Jun 19, 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
K060510 · JJX
Drew Scientific , Ltd.
Chemistry · 112d
Cleared Jun 16, 2006
EZ SMART-168 GLUCOSE MONITORING SYSTEM
K052818 · NBW
Tyson Bioresearch, Inc.
Chemistry · 255d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · JMO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Jun 15, 2006
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION...
K060364 · JKA
Teco Diagnostics
Chemistry · 122d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Abbott Laboratories
Chemistry · 76d
Cleared Jun 13, 2006
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
K061328 · NBW
E-San Limited
Chemistry · 32d
Cleared Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE...
K061296 · LPS
Diazyme Laboratories
Chemistry · 35d
Cleared Jun 13, 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280 · JIL
Iris International, Inc.
Chemistry · 131d
Cleared Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE...
K060632 · NBC
Ortho-Clinical Diagnostics, Inc.
Chemistry · 89d
Cleared Jun 06, 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · DJC
Acro Biotech, LLC
Chemistry · 222d
Cleared Jun 05, 2006
GLUCOPACK
K052469 · NBW
Healthpia America Corp.
Chemistry · 270d
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282 · JIT
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 02, 2006
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM,...
K061073 · DXN
Taidoc Technology Corporation
Chemistry · 46d
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · JIS
Dade Behring, Inc.
Chemistry · 27d
Cleared May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196 · JJY
Microgenics Corp.
Chemistry · 32d
Cleared May 30, 2006
NOD CHEMISTRY CONTROL
K060850 · JJY
Bioresource Technology, Inc.
Chemistry · 63d
Cleared May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX...
K061238 · KHS
Dade Behring, Inc.
Chemistry · 22d
Cleared May 25, 2006
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
K061182 · JJY
Cliniqa Corporation
Chemistry · 28d