# K962523: N Latex CRP Mono Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jul 10, 1996 after 41 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- 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: 1 generation back to K860894 (1986). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.

## Most influential descendants
- K981638: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent (1998), 4 descendants of its own
- K050836: CRP Diagnostic Assay (2005), 1 descendant of its own
- K192118: CRP Vario (2019), 0 descendants of its own
- K022690: Paros CRP (2002), 0 descendants of its own
- K990704: Array 360 System C-Reactive Protein (CRP Mpe) Reagent (1999), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K962523
Methodology: https://510kreport.com/methodology