AST Support of Docket No. FDA-2013-D-1358
Wednesday, February 19, 2014
The AST recently submitted a letter to the Food and Drug Administration regarding draft guidance for (510(k)) submissions for nucleic acid-based HLA test kits. The AST endorsed comments from the American Society for Histocompatibility and Immunogenetics (ASHI) regarding this FDA draft guidance for industry Docket.
News
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