# K855221: Seratest RF (Hemagglutination) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Apr 22, 1986 after 113 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970373: Raichem Rheumatoid Factor Spia (1997), 0 descendants of its own
- K962836: Hemagen Rheumatoid Factor Kit (Eia Method) (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K855221
Methodology: https://510kreport.com/methodology