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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 K132338
Device Name DA01 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
DELBIO INCORPORATION
3F,6F, 7F No.252, Shangying Road,
Guishan Industrial Zone
Taoyuan County,  TW 33341
Applicant Contact ERICA LI
Correspondent
DELBIO INCORPORATION
3F,6F, 7F No.252, Shangying Road,
Guishan Industrial Zone
Taoyuan County,  TW 33341
Correspondent Contact ERICA LI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JQP  
Date Received07/26/2013
Decision Date 10/24/2013
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
Predetermined Change
Control Plan Authorized		 No
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