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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK123007
Test Name MicoBioMed Co Ltd, Veri-Q Plus MGD-1001 Blood Glucose Monitoring System  
Manufacturer NameMico Biomed Co., Ltd.
Consumer Information Phone Number1(855)241-0148
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/24/2013
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K123007
Device Name VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Mico Biomed Co., Ltd.
55-13, Singeonji-Dong
Anseong,  KR 456-781
Applicant Contact Priscilla Chung
Correspondent
Mico Biomed Co., Ltd.
55-13, Singeonji-Dong
Anseong,  KR 456-781
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/27/2012
Decision Date 06/19/2013
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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