# K984132: Immulite C-Reactive Protein, Models LKC1, LKC5

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 28, 1999 after 71 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 K944288 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944288: Hemagen C-Reactive Protein Kit (Eia Method), Hemagen Diagnostics, Inc. (1994) Summary page 1.

## Most influential descendants
- K990886: Immulite C-Reactive Protein, Model LKCR1, LKCR5 (1999), 0 descendants of its own

## Indications for use
IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of C-reactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K984132
Methodology: https://510kreport.com/methodology