FDA 510(k) Applications Submitted by Hycor Biomedical

FDA 510(k) Number Submission Date Device Name Applicant
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
K191510 06/06/2019 Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae Hycor Biomedical
K182479 09/10/2018 NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus Hycor Biomedical


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