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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K113343
Device Name DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
Applicant
DELBIO INCORPORATION
3F, NO. 252, SHANGYING ROAD
GUISHAN INDUSTRIAL ZONE
TAOYUAN COUNTY,  TW 33341
Applicant Contact NICKY PAN
Correspondent
DELBIO INCORPORATION
3F, NO. 252, SHANGYING ROAD
GUISHAN INDUSTRIAL ZONE
TAOYUAN COUNTY,  TW 33341
Correspondent Contact NICKY PAN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received11/14/2011
Decision Date 02/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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