NOVEOS Specific IgE (sIgE) +5 more— 510(k) K261027
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K261027 for NOVEOS Specific IgE (sIgE) +5 more, Substantially Equivalent on 2026-07-24. Applicant: Hycor Biomedical. Device class: 2.
Summary
Hycor Biomedical's clearance covers NOVEOS Specific IgE (sIgE) and five capture reagents: F014 Soybean, F017 Hazelnut, and three peanut reagents (F352 Ara h 8 PR-10, F423 Ara h 2, and F447 Ara h 6). 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 came in as a Traditional 510(k).
Hycor filed from Garden Grove, California. Review took 116 calendar days (March 30 to July 24, 2026).
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, 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
Recent devices under product code DHB
view all- K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
- K260591 — NOVEOS Specific IgE (sIgE) +5 more
- K260280 — NOVEOS Specific IgE (sIgE) +5 more
- K260059 — NOVEOS Specific IgE (sIgE) +8 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.