# K991409: K-Assay Rheumatoid Factor

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Jun 9, 1999 after 48 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The K-ASSAY Rheumatoid Factor is intended to be used for the quantitative determination of human rheumatoid factor in human serum by immunoturbidimetric assay.

Source page: https://510kreport.com/device/K991409
Methodology: https://510kreport.com/methodology