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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K113764
Device Name GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
Original Applicant
BIONOSTICS, INC.
7 jackson rd.
devens,  MA  01434
Original Contact randy byrd
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/21/2011
Decision Date 01/30/2012
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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