NOVEOS Specific IgE (sIgE) +5 more— 510(k) K260280
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K260280 for NOVEOS Specific IgE (sIgE) +5 more, Substantially Equivalent on 2026-06-18. Applicant: Hycor Biomedical. Device class: 2.
Summary
Hycor Biomedical's clearance covers NOVEOS Specific IgE (sIgE) and five capture reagents: F004 (wheat), F023 (crab), F079 (gluten, wheat), F202 (cashew nut), and F233 (Gal d 1 ovomucoid egg). 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 the submission was a Traditional 510(k).
Hycor filed from Garden Grove, California. The decision came 140 calendar days after receipt (January 29 to June 18, 2026).
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg
- 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.