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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 K052469
Device Name GLUCOPACK
Applicant
Healthpia America Corp.
21 Grand Ave.
South Bldg., Suite 604
Palisades Park,  NJ  07650
Applicant Contact STEVEN KIM
Correspondent
Healthpia America Corp.
21 Grand Ave.
South Bldg., Suite 604
Palisades Park,  NJ  07650
Correspondent Contact STEVEN KIM
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received09/08/2005
Decision Date 06/05/2006
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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