NOVEOS Specific IgE (sIgE) Assay +9 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242531

Identifiers

510(k) Number: K242531 FDA 510(k)
FDA Product Code: DHB FDA 510(k)
Models / Variants: NOVEOS Specific IgE (sIgE) Assay FDA 510(k)
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Capture Reagent G002, Bermuda Grass (Cynodon dactylon) FDA 510(k)
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia) FDA 510(k)
Capture Reagent E005, Dog Dander (Canis familiaris) FDA 510(k)
Capture Reagent T003, Common Silver Birch (Betula verrucosa) FDA 510(k)
Capture Reagent F001, Egg White (Gallus gallus) FDA 510(k)
Capture Reagent F002, Cow's Milk (Bos taurus) FDA 510(k)
NOVEOS Immunoassay Analyz 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) Assay +9 more models by Hycor Biomedical — Class II — FDA_510K — listed in FDA 510(k) — 10 models — regulatory data on deviCERTS

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	K242531	Class II	Active

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Manufacturer

Manufacturer: Hycor Biomedical

Sources (1)

FDA 510(k) K242531 24 fields · synced Jun 18, 2026