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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 K103329
Device Name DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
Applicant
Delbio Incorporation
252, Shangying Rd.
Guishan Industrial Zone
Taoyuan County,  TW 33341
Applicant Contact NICKY PAN
Correspondent
Delbio Incorporation
252, Shangying Rd.
Guishan Industrial Zone
Taoyuan County,  TW 33341
Correspondent Contact NICKY PAN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received11/12/2010
Decision Date 03/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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