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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 K060620
Device Name ACCU-CHEK AVIVA TEST STRIPS
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Original Contact scott thiel
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/08/2006
Decision Date 08/11/2006
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
Recalls CDRH Recalls
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