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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 K123851
Device Name GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
Applicant
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01434
Applicant Contact RANDY BYRD
Correspondent
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01434
Correspondent Contact RANDY BYRD
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/14/2012
Decision Date 02/14/2013
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
Predetermined Change
Control Plan Authorized		 No
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