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.
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
- 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
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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.