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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 K022171
Device Name ACCU-CHEK COMPACT SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Original Contact scott thiel
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received07/03/2002
Decision Date 07/23/2002
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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