# K990824: Revised C-Reactive Protein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 16, 1999 after 35 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K962406 (1996). 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)
- K962406: N CRP Standard SY, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The Revised C-Reactive Protein Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for the Revised C-Reactive Protein (RCRP) method.

Source page: https://510kreport.com/device/K990824
Methodology: https://510kreport.com/methodology