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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 K122340
Device Name PRODIGY CHOICE
Applicant
PRODIGY DIABETES CARE, LLC
1468 Harwell Avenue
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
PRODIGY DIABETES CARE, LLC
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/02/2012
Decision Date 11/26/2013
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
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