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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 K113614
Device Name ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0457
Original Contact michael flis
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received12/06/2011
Decision Date 02/12/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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