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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 K021513
Device Name ACCU-CHEK ADVANTAGE MODULE
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact Scott Thiel
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact Scott Thiel
Regulation Number862.1345
Classification Product Code
NBW  
Date Received05/09/2002
Decision Date 06/11/2002
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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