NOVEOS Specific IgE (sIgE) +8 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260059

Identifiers

510(k) Number: K260059 FDA 510(k)
FDA Product Code: DHB FDA 510(k)
Models / Variants: NOVEOS Specific IgE (sIgE) FDA 510(k)
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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) +8 more models by Hycor Biomedical Llc — Class II — FDA_510K — listed in FDA 510(k) — 9 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	K260059	Class II	Active

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Manufacturer

Manufacturer: Hycor Biomedical Llc
FDA Applicant: Hycor Biomedical

Sources (1)

FDA 510(k) K260059 24 fields · synced Jun 18, 2026