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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 (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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