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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drug metabolizing enzyme genotyping systems
510(k) Number K051824
Device Name INVADER UGT1A1 MOLECULAR ASSAY
Original Applicant
THIRD WAVE TECHNOLOGIES, INC.
502 south rosa rd.
madison,  WI  53719 1256
Original Contact sam rua
Regulation Number862.3360
Classification Product Code
NTI  
Date Received07/05/2005
Decision Date 08/18/2005
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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