# K925274: Autocomp (TM) Software and Calibrite (TM) Beads

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Sep 30, 1994 after 711 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K961623: Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads (1996), 12 descendants of its own
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set (1998), 11 descendants of its own
- K041074: BD Facscanto with BD Facsanto Software (2004), 6 descendants of its own
- K040725: BD Facscanto System (2004), 4 descendants of its own
- K060375: BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 (2006), 3 descendants of its own

Source page: https://510kreport.com/device/K925274
Methodology: https://510kreport.com/methodology