Substantially Equivalent 510(k) Device Information
Applicant: Genetic Testing Institute, Brookfield, WI
510(k) number: BK960059
Product: PAKAUTO Platelet Antibody Screening Kit
Date: 10/22/98
Summary of Safety and Effectiveness
July 3, 1996
510(k) GTI PAKAUTO Screening Test for Autoantibodies to Platelet Glycoproteins, IIb/IIIa, Ib/IX, and Ia/IIa
This statement regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I certify that Genetic Testing Institute will make available all information included in this premarket notification on safety and effectiveness that supports a finding of substantial equivalent within 30 days of request by any person. The information to be made available will not include confidential patient identifiers or confidential or trade secret manufacturing process information.
--- Signature ---
Michael Moghaddam
___7-5-96___
Date
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