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Genetic Testing Institute

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K082205 FACTOR VIII ANTIBODY SCREENGGP2008-11-20 View
510(k) K071781 PF4 IGGLCO2007-12-19 View
510(k) K053559 PF4 ENHANCED SOLID PHASE ELISALCO2006-01-20 View
510(k) K993553 GTI-FVIII INHIBITOR ASSAYGGP2000-02-01 View
510(k) K983379 GTI-PF4 ELISALCO1999-03-09 View
510(k) K841114 ALLO-TYPE HUMAN IMMUNOGLOBULIN-DGX1984-06-14 View
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