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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 K083263
Device Name SYMCARE DIABETES MANAGEMENT PROGRAM
Applicant
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC
200 LAWRENCE DRIVE
west chester,  PA  19380
Applicant Contact rae ann delay
Correspondent
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC
200 LAWRENCE DRIVE
west chester,  PA  19380
Correspondent Contact rae ann delay
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received11/05/2008
Decision Date 03/13/2009
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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