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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 K130138
Device Name SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Original Contact justin davis
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received01/18/2013
Decision Date 03/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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