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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 K103115
Device Name PRODIGY DIABETES MANAGEMENT SOFTWARE
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
JQP  
Date Received10/21/2010
Decision Date 10/12/2011
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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