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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 K091168
Device Name GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
Applicant
INFOPIA CO., LTD
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
INFOPIA CO., LTD
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received04/22/2009
Decision Date 05/27/2010
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
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