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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
Applicant
THIRD WAVE TECHNOLOGIES, INC.
502 SOUTH ROSA RD.
MADISON,  WI  53719 -1256
Applicant Contact Sam Rua
Correspondent
THIRD WAVE TECHNOLOGIES, INC.
502 SOUTH ROSA RD.
MADISON,  WI  53719 -1256
Correspondent Contact Sam Rua
Regulation Number862.3360
Classification Product Code
NTI  
Date Received07/05/2005
Decision Date 08/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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