NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 more— 510(k) K252775
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K252775 for NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 more, Substantially Equivalent on 2026-01-16. Applicant: Hycor Biomedical. Device class: 2.
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
- Applicant
- Hycor Biomedical
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.