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Ferritin Kit

by Hybritech, Inc. 510(k)

Active United States

510(k) K812597

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812597 Date19 Oct 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DBF
Device Class
Class II
Regulation
21 CFR Part 866.5340
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ferritin Kit is an immunology device used for antigen, antiserum, and control purposes. It is classified as a Class 2 device with product code DBF. The device is substantially equivalent to other devices on the market.

The Ferritin Kit is supplied by Hybritech, Inc. and has been cleared through the Traditional 510(k) pathway. It is regulated under regulation number 866.5340 and has been assigned the FDA clearance number K812597. The device is stored and distributed in accordance with standard medical device protocols.

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