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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
510(k) Number K063787
Device Name INPLEX CF MOLECULAR TEST
Applicant
THIRD WAVE TECHNOLOGIES, INC.
502 SOUTH ROSA RD.
MADISON,  WI  53719 -1256
Applicant Contact ANDREW A LUKOWIAK
Correspondent
THIRD WAVE TECHNOLOGIES, INC.
502 SOUTH ROSA RD.
MADISON,  WI  53719 -1256
Correspondent Contact ANDREW A LUKOWIAK
Regulation Number866.5900
Classification Product Code
NUA  
Date Received12/21/2006
Decision Date 03/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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