Centria Ferritin Ria
by Union Carbide Corp. 510(k)
Active
510(k) K792449
Overview
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.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792449 | Date31 Dec 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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