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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK130244
Test Name DELBio Incorporation DiaTrue Plus Blood Glucose Monitoring System  
Manufacturer NameDELBIO INCORPORATION
Consumer Information Phone Number(855)933-5246
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date08/27/2013
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K130244
Device Name DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
Applicant
DELBIO INCORPORATION
3F,6F, 7F No.252, Shangying Road,
Guishan Industrial Zone
Taoyuan County,  TW 33341
Applicant Contact NICKY PAN
Correspondent
DELBIO INCORPORATION
3F,6F, 7F 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   JQP  
Date Received01/31/2013
Decision Date 08/23/2013
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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