NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252775

Identifiers

510(k) Number: K252775 FDA 510(k)
FDA Product Code: DHB FDA 510(k)
Models / Variants: NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) FDA 510(k)
Capture Reagent F076, Bos d 4 a-lactalbumin, Milk FDA 510(k)
Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk FDA 510(k)
Capture Reagent F232, Gal d 2 Ovalbumin, Egg FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 866.5750 FDA 510(k)
Regulation Number: 866.5750 FDA 510(k)
Advisory Committee: Immunology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 … by Hycor Biomedical — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K252775	Class II	Active

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Manufacturer

Manufacturer: Hycor Biomedical

Sources (1)

FDA 510(k) K252775 24 fields · synced Jun 19, 2026