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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK102816
Test Name Apex Biotechnology Corp. GAL-1C Blood Glucose Monitoring System  
Manufacturer NameAPEX BIOTECHNOLOGY CORP.
Consumer Information Phone Number1(877)979-5454
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date09/20/2011
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K102816
Device Name GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
Applicant
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Applicant Contact HSUE-MEI LEE
Correspondent
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Correspondent Contact HSUE-MEI LEE
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/28/2010
Decision Date 09/15/2011
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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