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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 K063068
Device Name FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
Applicant
ARKRAY USA, INC.
5182 WEST 76TH ST.
MINNEAPOLIS,  MN  55439
Applicant Contact TOM SPEIKERS
Correspondent
ARKRAY USA, INC.
5182 WEST 76TH ST.
MINNEAPOLIS,  MN  55439
Correspondent Contact TOM SPEIKERS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received10/06/2006
Decision Date 12/20/2006
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
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