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Allegro Ferritin Immunoassay System

by Nichols Institute Diagnostics 510(k)

Active United States

510(k) K874572

Overview

The Allegro Ferritin Immunoassay System is a device used for the quantitative measurement of ferritin in human serum or plasma. This immunological test system aids in the assessment of iron stores and diagnosis of conditions related to iron metabolism.

The system is supplied as a single-use device and is intended for laboratory use. It has received FDA 510(k) clearance with the product code DBF and is classified under device class 2. The device is regulated under the regulation number 866.5340.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874572 Date2 Dec 1987ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Allegro (Tm) Ferritin Immunoassay System
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

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Questions

  • What is the Allegro Ferritin Immunoassay System used for?

    The Allegro Ferritin Immunoassay System is used for the quantitative measurement of ferritin in human serum or plasma, aiding in the assessment of iron stores and diagnosis of conditions related to iron metabolism.

  • Is the Allegro Ferritin Immunoassay System a single-use device?

    Yes, the Allegro Ferritin Immunoassay System is supplied as a single-use device and is intended for laboratory use only.

  • What is the regulatory status of the Allegro Ferritin Immunoassay System?

    The Allegro Ferritin Immunoassay System has received FDA 510(k) clearance with the product code DBF and is classified under device class 2, regulated under the regulation number 866.5340.

  • What is the manufacturer of the Allegro Ferritin Immunoassay System?

    The Allegro Ferritin Immunoassay System is manufactured by Nichols Institute Diagnostics, located in Los Angeles, California.