NOVEOS Specific IgE (sIgE) +5 more— 510(k) K260591
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K260591 for NOVEOS Specific IgE (sIgE) +5 more, Substantially Equivalent on 2026-07-21. Applicant: Hycor Biomedical. Device class: 2.
Summary
Hycor Biomedical's clearance covers NOVEOS Specific IgE (sIgE) and five capture reagents: F010 Sesame Seed, F020 Almond, F078 Bos d 8 Casein (Milk), F080 Lobster, and F422 Ara h 1 (Peanut). They're filed under DHB, radioallergosorbent (RAST) immunological test systems.
Class II, 21 CFR 866.5750. Immunology is both the classification panel and the review panel, and it was a Traditional 510(k).
Hycor filed from Garden Grove, California. Review took 148 calendar days (February 23 to July 21, 2026).
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
- Applicant
- Hycor Biomedical
- Product code
- Product 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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More clearances from Hycor Biomedical
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- K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus +1 more
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Data sourced from openFDA. This site is unofficial and independent of the FDA.