# K983340: Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System Ferritin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 14, 1998 after 82 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K941365: Mpi Denture Adhesive Film Seals, Medical Polymers, Inc. (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay. Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.

Source page: https://510kreport.com/device/K983340
Methodology: https://510kreport.com/methodology