# K926124: Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 Mon

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Jul 6, 1993 after 214 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
3 of 19 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
- K982172: Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col (1998), 16 descendants of its own
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla (1999), 14 descendants of its own
- K030828: Tetracxp System (Software and System Guide) (2003), 6 descendants of its own
- K130373: Navios Flow Cytometer System (2013), 3 descendants of its own
- K162897: Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (2017), 2 descendants of its own

Source page: https://510kreport.com/device/K926124
Methodology: https://510kreport.com/methodology