# K051633: CD-Chex Plus BC

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Aug 16, 2005 after 57 days
- Product code: GGL (Control, White-Cell)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K920997 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960894: CD-Chex + RBC, Streck Laboratories, Inc. (1996) Summary page 1.

## Most influential descendants
- K083926: CD4 Count (2009), 0 descendants of its own

## Indications for use
CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.

Source page: https://510kreport.com/device/K051633
Methodology: https://510kreport.com/methodology