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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 K032552
Device Name ACCU-CHEK ADVANTAGE SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Original Contact scott thiel
Regulation Number862.1345
Classification Product Code
NBW  
Date Received08/19/2003
Decision Date 09/12/2003
Decision substantially equivalent - CLIA submission (CS)
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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