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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090389
Test Name Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System  
Manufacturer NameBestgen Biotech Corp.
Consumer Information Phone Number1(888)873-1021
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date10/14/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090389
Device Name AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Bestgen Biotech Corp.
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
Bestgen Biotech Corp.
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received02/17/2009
Decision Date 07/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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