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
1465–1488 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 30, 2011
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K110846 · JJW
Randox Laboratories Limited
Chemistry · 186d
Cleared Sep 27, 2011
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516 · LBS
Liposcience, Inc.
Chemistry · 118d
Cleared Sep 27, 2011
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
K103396 · NBW
I-Sens, Inc.
Chemistry · 312d
Cleared Sep 23, 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE...
K112071 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 65d
Cleared Sep 21, 2011
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
K110435 · NBW
U. S. Diagnostics, Inc.
Chemistry · 218d
Cleared Sep 21, 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
K110061 · JJX
Siemens Healthcare Diagnostics
Chemistry · 254d
Cleared Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299 · LFR
Roche Diagnostics
Chemistry · 499d
Cleared Sep 19, 2011
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
K112356 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Sep 19, 2011
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236 · LAF
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 46d
Cleared Sep 16, 2011
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD...
K111728 · CGA
Eps Bio Technology Corp.
Chemistry · 88d
Cleared Sep 16, 2011
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
K100806 · NBW
Delbio Incorporation
Chemistry · 543d
Cleared Sep 15, 2011
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
K102816 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 14, 2011
ELECSYS MYOGLOBIN CALCHECK 5
K112113 · JJX
Roche Diagnostics
Chemistry · 51d
Cleared Sep 14, 2011
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K111996 · JJY
Elitechgroup
Chemistry · 63d
Cleared Sep 08, 2011
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL...
K110818 · CIX
Polymedco, Inc.
Chemistry · 168d
Cleared Sep 08, 2011
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT,...
K103615 · CDN
Alfa Wassermann Diagnostic...
Chemistry · 273d
Cleared Sep 07, 2011
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD...
K112272 · LFR
Eps Bio Technology Corp.
Chemistry · 30d
Cleared Sep 07, 2011
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
K110637 · LFR
Cilag GmbH International
Chemistry · 187d
Cleared Sep 06, 2011
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN...
K111650 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 85d
Cleared Sep 02, 2011
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE...
K101631 · NBW
Taidoc Technology Corporation
Chemistry · 449d
Cleared Sep 01, 2011
POLY-CHEM 90 TOTAL BILIRUBIN
K111143 · CIG
Polymedco, Inc.
Chemistry · 132d
Cleared Aug 31, 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G,...
K103747 · LBS
Elitechgroup Seppim S.A.S.
Chemistry · 251d
Cleared Aug 31, 2011
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE...
K101635 · NBW
Taidoc Technology Corporation
Chemistry · 447d
Cleared Aug 31, 2011
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL...
K101204 · CGA
Apex BioTechnology Corp.
Chemistry · 488d