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FDA 510(k) Applications Submitted by GENETIC TESTING INSTITUTE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K841114
03/15/1984
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
GENETIC TESTING INSTITUTE
K053559
12/21/2005
PF4 ENHANCED SOLID PHASE ELISA
GENETIC TESTING INSTITUTE
K983379
09/25/1998
GTI-PF4 ELISA
GENETIC TESTING INSTITUTE
K993553
10/20/1999
GTI-FVIII INHIBITOR ASSAY
GENETIC TESTING INSTITUTE
K082205
08/05/2008
FACTOR VIII ANTIBODY SCREEN
GENETIC TESTING INSTITUTE
K071781
07/02/2007
PF4 IGG
GENETIC TESTING INSTITUTE
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