# K961277: RF Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: May 8, 1996 after 35 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 1 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 9, 2001 · Not classified · Z-1031-03: Calibrator C not meeting its optical density specification.

Source page: https://510kreport.com/device/K961277
Methodology: https://510kreport.com/methodology