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
2881–2904 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 07, 2003
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
K033061 · JIX
Diamond Diagnostics, Inc.
Chemistry · 39d
Cleared Nov 07, 2003
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697 · JIS
Dade Behring, Inc.
Chemistry · 66d
Cleared Nov 05, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · DDR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 03, 2003
ATAC HEMOGLOBIN A1C REAGENT KIT
K031042 · LCP
Clinical Data, Inc.
Chemistry · 216d
Cleared Oct 31, 2003
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · LAR
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 31, 2003
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · LAN
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 30, 2003
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A)...
K032798 · JHM
Dade Behring, Inc.
Chemistry · 51d
Cleared Oct 30, 2003
GLYCOHEMOSURE HBA1C CONTROL
K032791 · GGM
Quantimetrix Corp.
Chemistry · 52d
Cleared Oct 30, 2003
FERTELL FEMALE FERTILITY TEST
K032002 · NGA
Genosis, Inc.
Chemistry · 125d
Cleared Oct 27, 2003
FLUID SAMPLE RETRIEVAL SYSTEM
K030394 · JKA
Biomed Personal Metabolic and...
Chemistry · 264d
Cleared Oct 21, 2003
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
K032985 · NBW
Hmd Biomedical, Inc.
Chemistry · 27d
Cleared Oct 21, 2003
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
K032608 · JIS
Gonotec Gesellschaft Fuer Mess-Und...
Chemistry · 57d
Cleared Oct 21, 2003
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K032074 · JJY
Cliniqa Corporation
Chemistry · 106d
Cleared Oct 21, 2003
COMBI-SCREEN, MODELS 10SL AND 11SL
K023885 · JIL
Analyticon Biotechnologies AG
Chemistry · 334d
Cleared Oct 20, 2003
EPT CERTAINTY PREGNANCY TEST
K032939 · LCX
Unipath , Ltd.
Chemistry · 28d
Cleared Oct 20, 2003
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD...
K032819 · JJX
Bionostics, Inc.
Chemistry · 40d
Cleared Oct 17, 2003
MICROGENICS CYCLOSPORINE CONTROL KIT
K032842 · LAS
Microgenics Corp.
Chemistry · 36d
Cleared Oct 17, 2003
ROCHE DIAGNOSTICS OMNI S ANALYZER
K032311 · CEM
Roche Diagnostics Corp.
Chemistry · 81d
Cleared Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009 · CIX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Oct 16, 2003
EASYGLUCO, MODEL IGM0002
K031501 · NBW
American Healthcare, Inc.
Chemistry · 156d
Cleared Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
K033185 · CJE
Roche Diagnostics Corp.
Chemistry · 13d
Cleared Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · DLJ
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661 · LCX
ACON Laboratories, Inc.
Chemistry · 47d
Cleared Oct 10, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162 · JJY
Cliniqa Corporation
Chemistry · 10d