# K071247: N Latex RF Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 8, 2007 after 96 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 K942328 (1994). 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)
- K942328: N Latex RF, Behring Diagnostics, Inc. (1994) Summary page 1.

## Indications for use
Quantitative determination of rheumatoid factors (RF) in human serum, heparinized and EDTA plasma on the BNTM II and BN ProSpec Systems as an aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K071247
Methodology: https://510kreport.com/methodology