# K993273: N Latex Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 23, 1999 after 54 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
Longest line of descent: 1 generation back to K950707 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950707: N Latex Ferritin, Behring Diagnostics, Inc. (1995) Summary page 1.

## Most influential descendants
- K110736: Advia Chemistry Ferritin (FRT) Method (2011), 0 descendants of its own

## Indications for use
N Latex Ferritin is an in vitro diagnostic reagent for the quantitative determination of ferritin in human serum or heparinized plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Source page: https://510kreport.com/device/K993273
Methodology: https://510kreport.com/methodology