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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K082205
Device Name FACTOR VIII ANTIBODY SCREEN
Applicant
Genetic Testing Institute
20925 Crossroads Cir.
Suite 200
Waukesha,  WI  53186
Applicant Contact MICHELLE A STAPLETON
Correspondent
Genetic Testing Institute
20925 Crossroads Cir.
Suite 200
Waukesha,  WI  53186
Correspondent Contact MICHELLE A STAPLETON
Regulation Number864.7290
Classification Product Code
GGP  
Date Received08/05/2008
Decision Date 11/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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