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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 K021448
Device Name MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis,  IN  46250 0457
Original Contact mike flis
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received05/06/2002
Decision Date 06/03/2002
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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