# K000076: Cell-Chex

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Mar 3, 2000 after 53 days
- Product code: GJR (Control, Red-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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K051706: IQ Body Fluids Control (2005), 6 descendants of its own
- K053362: Cell-Chex Auto (2006), 5 descendants of its own
- K120744: XN Check BF (2012), 2 descendants of its own
- K141957: XN Check BF (2014), 1 descendant of its own
- K101335: Cell-Chex (2010), 1 descendant of its own

Source page: https://510kreport.com/device/K000076
Methodology: https://510kreport.com/methodology