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
1777–1800 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 21, 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY...
K092051 · JJY
Microgenics Corp.
Chemistry · 76d
Cleared Sep 18, 2009
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
K091898 · NBW
Taidoc Technology Corporation
Chemistry · 86d
Cleared Sep 16, 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · CFR
Medica Corp.
Chemistry · 30d
Cleared Sep 11, 2009
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE...
K082811 · JIO
Urit Medical Electronic Co., Ltd.
Chemistry · 352d
Cleared Sep 09, 2009
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
K091544 · CFJ
Alfa Wassermann, Inc.
Chemistry · 105d
Cleared Sep 09, 2009
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
K090104 · JJX
DiaSorin, Inc.
Chemistry · 237d
Cleared Sep 05, 2009
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
K092645 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 9d
Cleared Sep 04, 2009
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · CIG
Medica Corp.
Chemistry · 64d
Cleared Sep 04, 2009
UCP HOME DRUG SCREENING TESTS
K091588 · DKZ
Ucp Biosciences, Inc.
Chemistry · 94d
Cleared Sep 03, 2009
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR...
K091861 · JGS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 76d
Cleared Sep 03, 2009
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
K090846 · JLW
Perkinelmer, Inc.
Chemistry · 157d
Cleared Sep 02, 2009
WIENER LAB. URINE STRIP 10 AND 11
K083724 · JIO
Wiener Laboratorios Saic
Chemistry · 261d
Cleared CT Aug 31, 2009
VS-SENSE TEST
K091287 · CEN
Common Sense , Ltd.
Chemistry · 122d
Cleared Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING...
K083867 · CDZ
Beckman Coulter, Inc.
Chemistry · 241d
Cleared CT Aug 26, 2009
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS
K091820 · NBW
Bayer Healthcare
Chemistry · 69d
Cleared Aug 25, 2009
BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
K091292 · JKA
Becton, Dickinson and Company (BD)
Chemistry · 113d
Cleared Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · MMI
Roche Diagnostics
Chemistry · 338d
Cleared Aug 18, 2009
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
K091481 · NBW
Eps Bio Technology Corp.
Chemistry · 91d
Cleared Aug 17, 2009
PATHFAST CK-MB-II, PATHFAST MYO-II
K081360 · JHX
Mitsubishi Kagaku Iatron
Chemistry · 459d
Cleared Aug 14, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742 · JFY
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Aug 14, 2009
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME...
K091455 · MZV
Diazyme Laboratories
Chemistry · 88d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · JJX
Siemens Healthcare Diagnostics
Chemistry · 119d
Cleared Aug 14, 2009
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
K090332 · NBW
Arkray Factory USA, Inc.
Chemistry · 185d
Cleared Aug 06, 2009
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
K091460 · JJX
American Biological Technologies, Inc.
Chemistry · 80d