FDA 510(k) Applications Submitted by Irene M. Guzman

FDA 510(k) Number	Submission Date	Device Name	Applicant
K152408	08/25/2015	Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack	FOCUS DIAGNOSTICS, INC.
K220162	01/20/2022	Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria	Hycor Biomedical
K200825	03/30/2020	NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense	Hycor Biomedical
K163085	11/03/2016	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack	Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC