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— 510(k) K260280
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K260280 for 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, Substantially Equivalent on 2026-06-18. Applicant: Hycor Biomedical.
Clearance details
- Applicant
- Hycor Biomedical
- Product code
- Code DHB
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.