NOVEOS Specific IgE (sIgE) +8 more— 510(k) K260059
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K260059 for NOVEOS Specific IgE (sIgE) +8 more, Substantially Equivalent on 2026-05-15. Applicant: Hycor Biomedical. Device class: 2.
Summary
Hycor Biomedical's record covers NOVEOS Specific IgE (sIgE) and eight capture reagents: Brazil Nut (F018), Coconut (F036), Tuna (F040), Salmon (F041), Egg Yolk (F075), Pecan Nut (F201), Pistachio Nut (F203) and Oyster (F290). The product code is 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. Review took 127 calendar days (January 8 to May 15, 2026).
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)
- 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
Recent devices under product code DHB
view all- K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
- K261027 — NOVEOS Specific IgE (sIgE) +5 more
- K260591 — NOVEOS Specific IgE (sIgE) +5 more
- K260280 — NOVEOS Specific IgE (sIgE) +5 more
- K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 more
More clearances from Hycor Biomedical
view all- K252493 — NOVEOS Specific IgE (sIgE) +4 more
- K242531 — NOVEOS Specific IgE (sIgE) Assay +9 more
- K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
- K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus +1 more
- K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
Data sourced from openFDA. This site is unofficial and independent of the FDA.