# K942328: N Latex RF

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Oct 20, 1994 after 168 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.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices 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.

## Most influential descendants
- K963048: Immage System Rheumatoid Factor (RF) Reagent (1996), 2 descendants of its own
- K963292: Cobas Integra Reagent Cassettes & Ancillary Reagents (1996), 1 descendant of its own
- K071247: N Latex RF Kit (2007), 0 descendants of its own
- K031650: Ferritin Generation 2 (2003), 0 descendants of its own
- K971602: Array Systems Rheumatoid Factor (Rfmpe) Reagent (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K942328
Methodology: https://510kreport.com/methodology