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
1201–1224 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 05, 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I...
K123050 · LCX
Nantong Biotechnology Co., Ltd.
Chemistry · 130d
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · CIG
Abbott Laboratories
Chemistry · 210d
Cleared Feb 01, 2013
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
K121456 · KQO
Arkray, Inc.
Chemistry · 261d
Cleared Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL...
K123775 · JJY
Bio-Rad Laboratories
Chemistry · 52d
Cleared Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
K123966 · JJX
Bionostics, Inc.
Chemistry · 30d
Cleared Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE...
K123008 · NBW
Bionime Corporation
Chemistry · 120d
Cleared Jan 25, 2013
LIAISON TESTOSTERONE
K122793 · CDZ
DiaSorin, Inc.
Chemistry · 135d
Cleared Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
K123612 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 55d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372 · JIX
Abbott Laboratories
Chemistry · 74d
Cleared Jan 14, 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
K121706 · CGA
Foracare, Inc.
Chemistry · 220d
Cleared Jan 10, 2013
BLOOD CULTURE HOLDER
K122687 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 128d
Cleared Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
K123798 · JJX
Bio-Rad Laboratories
Chemistry · 30d
Cleared Jan 01, 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K121944 · CIB
DiaSorin, Inc.
Chemistry · 182d
Cleared Dec 27, 2012
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
K123683 · MXA
Aerocrine AB
Chemistry · 27d
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Dec 27, 2012
QUICK SAMPLER HOLDER
K120490 · JKA
Nipro Medical Corporation
Chemistry · 314d
Cleared Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST...
K122961 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 87d
Cleared Dec 21, 2012
GLOOKO LOGBOOK CHARTS
K122142 · NBW
Glooko, Inc.
Chemistry · 155d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · DFC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
K122435 · LFR
Nova Biomedical Corporation
Chemistry · 132d
Cleared Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
K121027 · JIT
Diamond Diagnostics, Inc.
Chemistry · 260d
Cleared Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · NBW
ACON Laboratories, Inc.
Chemistry · 78d
Cleared Dec 12, 2012
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
K121842 · LCP
Axis-Shield Diagnostics, Ltd.
Chemistry · 170d
Cleared Dec 11, 2012
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K120866 · NBW
Delbio Incorporation
Chemistry · 264d