FDA 510(k) Applications Submitted by Hycor Biomedical
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K242531 |
08/26/2024 |
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); C |
Hycor Biomedical |
| 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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