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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 K993553
Device Name GTI-FVIII INHIBITOR ASSAY
Applicant
Genetic Testing Institute
150 N. Patrick Blvd.
Suite 100
Brookfield,  WI  53045 -5854
Applicant Contact MICHAEL MOGHADDAM
Correspondent
Genetic Testing Institute
150 N. Patrick Blvd.
Suite 100
Brookfield,  WI  53045 -5854
Correspondent Contact MICHAEL MOGHADDAM
Regulation Number864.7290
Classification Product Code
GGP  
Date Received10/20/1999
Decision Date 02/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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