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Centria Ferritin Ria

by Union Carbide Corp. 510(k)

Active United States

510(k) K792449

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792449 Date31 Dec 1979ClearedStatusActive

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  • Withdrawn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, 25 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 Centria Ferritin Ria is an immunology device used for ferritin antigen and antiserum testing. It is a radioimmunoassay (RIA) test designed to measure ferritin levels in patient samples.

This device is manufactured by Union Carbide Corp. and is supplied as a single-use product. It is not MRI compatible and requires standard storage conditions. The device received FDA 510(k) clearance with product code DBF and is classified as class II medical device.

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