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Amerlite Ferritin Assay (Additional Protocol)

by Amersham Corp. 510(k)

Active United States

510(k) K892362

Overview

The Amerlite Ferritin Assay (Additional Protocol) is an in vitro diagnostic device classified as a ferritin antigen assay, antiserum, and control set. It is designed to quantitatively measure ferritin levels in serum or plasma samples, aiding in the diagnosis and monitoring of conditions associated with iron metabolism disorders, such as anemia or hemochromatosis.

This device is supplied as a kit containing reagents, controls, and instructions for use, intended for single-use in clinical laboratory settings. It has received FDA 510(k) clearance under the product code DBF, classified as a Class II device under special controls. The assay requires standard laboratory equipment and adheres to immunology-based diagnostic protocols, with no MRI safety considerations. Storage and handling follow standard in vitro diagnostic device guidelines.

AI-generated from registry data, 19 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 NumberK892362 Date9 May 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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)

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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