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
1441–1464 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 04, 2011
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K111206 · DIC
Teco Diagnostics
Chemistry · 158d
Cleared Oct 04, 2011
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · LCX
Taidoc Technology Corporation
Chemistry · 312d
Cleared Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · NBW
Andon Medical Co., Ltd.
Chemistry · 10d
Cleared Sep 30, 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · JJY
Randox Laboratories, Ltd.
Chemistry · 183d
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