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
1753–1776 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 02, 2009
AIA-PACK RBC FOLATE
K091332 · CGN
Tosoh Bioscience, Inc.
Chemistry · 149d
Cleared Oct 02, 2009
EOCENE SYSTEM
K090712 · NBW
Infopia Co, Ltd.
Chemistry · 198d
Cleared Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · JGJ
Abaxis, Inc.
Chemistry · 98d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · JJX
Roche Diagnostics Corp.
Chemistry · 114d
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 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 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