# K920997: CD-Chex

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: May 31, 1992 after 90 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960894: CD-Chex + RBC (1996), 3 descendants of its own
- K961610: R & D Systems' Whole Blood Flow Control, (R & D - WBFC) (1996), 2 descendants of its own
- K051633: CD-Chex Plus BC (2005), 1 descendant of its own
- K982231: Statusflow (1998), 1 descendant of its own
- K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K920997
Methodology: https://510kreport.com/methodology