# K992517: Biocheck Ferritin Elisa Model BC-1025

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Sep 24, 1999 after 58 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.

Source page: https://510kreport.com/device/K992517
Methodology: https://510kreport.com/methodology