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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 K042795
Device Name CLEVER CHEK TD-3213
Original Applicant
4f, 88, sec.1, kwang fu road
san chung, taipei,  TW 241
Original Contact shu-mei wu
Regulation Number862.1345
Classification Product Code
Subsequent Product Codes
Date Received10/07/2004
Decision Date 03/07/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No