# K971833: Elecsys Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 2, 1997 after 14 days
- Product code: JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Enzymun-Test® Ferritin: named in the summary without a submission number

## Most influential descendants
- K193650: LIAISON Ferritin (2021), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay.‘ECLIA” us intended for use.on-the. .. - .. .- Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Source page: https://510kreport.com/device/K971833
Methodology: https://510kreport.com/methodology