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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 K103542
Device Name GENSTRIP TEST STRIP MODEL 100-201
Applicant
SHASTA TECHNOLOGIES, LLC
611 W 5TH ST.
3RD FLOOR
AUSTIN,  TX  78701
Applicant Contact CAROLINE TONTINI
Correspondent
SHASTA TECHNOLOGIES, LLC
611 W 5TH ST.
3RD FLOOR
AUSTIN,  TX  78701
Correspondent Contact CAROLINE TONTINI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received12/02/2010
Decision Date 11/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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