Hycor Biomedical - FDA 510(k) Cleared Devices
Recent clearances: NOVEOS Specific IgE (sIgE), NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea), NOVEOS Specific IgE (sIgE)
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hycor Biomedical Immunology ✕
9 devices
Cleared
Jun 18, 2026
NOVEOS Specific IgE (sIgE)
Immunology
140d
Cleared
May 15, 2026
NOVEOS Specific IgE (sIgE)
Immunology
127d
Cleared
Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
Immunology
136d
Cleared
Dec 23, 2025
NOVEOS Specific IgE (sIgE)
Immunology
137d
Cleared
Apr 23, 2025
NOVEOS Specific IgE (sIgE) Assay
Immunology
240d
Cleared
Feb 18, 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent...
Immunology
29d
Cleared
Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
Immunology
88d
Cleared
Jul 31, 2019
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent...
Immunology
55d
Cleared
Dec 04, 2018
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture...
Immunology
85d