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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name test, platelet antibody
510(k) Number BK980005
Tradename GTI PAT HPA-1 (PI) Genotyping Kit
Device Name Test, Platelet Antibody Test
Original Applicant
Genetic Testing Institute
150 n. patrick blvd.
brookfield,  WI  53045
Classification Product Code
MYP  
Date Received03/03/1998
Decision Date 04/23/1999
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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