# K962836: Hemagen Rheumatoid Factor Kit (Eia Method)

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Sep 12, 1996 after 52 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- 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 K855221 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K855221: Seratest RF (Hemagglutination) Kit, Hemagen Diagnostics, Inc. (1986) Summary page 1.

## Indications for use
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating IgM rheumatoid factor. When used according to instructions, the kit is useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatic diseases.

Source page: https://510kreport.com/device/K962836
Methodology: https://510kreport.com/methodology