# K964687: N Latex CRP Mono Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Dec 16, 1996 after 90 days
- Product code: DCH (System, Test, C-Reactive Protein, Rhodamine)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860894 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962523: N Latex CRP Mono Reagent, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The proposed test reagent (N Latex CRP._mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma.

Source page: https://510kreport.com/device/K964687
Methodology: https://510kreport.com/methodology