# K960703: RF-Latex Seiken Reagent System

- Pathway: 510(k) (Traditional)
- Applicant: Globe Management Support, Inc.
- Decided: Apr 19, 1996 after 59 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. The FDA summary names its predicate without a number.
- (no number) quantex RF plus: named in the summary without a submission number

## Indications for use
This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.

Source page: https://510kreport.com/device/K960703
Methodology: https://510kreport.com/methodology