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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K983379
Device Name GTI-PF4 ELISA
Applicant
Genetic Testing Institute
150 N. Patrick Blvd.
Suite 100
Brookfield,  WI  53045
Applicant Contact MICHAEL MOGHADDAM
Correspondent
Genetic Testing Institute
150 N. Patrick Blvd.
Suite 100
Brookfield,  WI  53045
Correspondent Contact MICHAEL MOGHADDAM
Regulation Number864.7695
Classification Product Code
LCO  
Date Received09/25/1998
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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