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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 K091815
Device Name SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
Applicant
Biotest Medical Corp.
2995 Steven Martin Dr.
Fairfax,  VA  22031
Applicant Contact DIANE MANDELL HORWITZ
Correspondent
Biotest Medical Corp.
2995 Steven Martin Dr.
Fairfax,  VA  22031
Correspondent Contact DIANE MANDELL HORWITZ
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received06/18/2009
Decision Date 11/16/2009
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
Predetermined Change
Control Plan Authorized		 No
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