# K961623: Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Monoclonal Center
- Decided: Jun 7, 1996 after 42 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
Longest line of descent: 1 generation back to K925274 (1994). 1 ancestor in all.
12 later devices descend from it; 3 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)
- K925274: Autocomp (TM) Software and Calibrite (TM) Beads, Becton Dickinson Immunocytometry Systems (1994) Summary page 1.

## Most influential descendants
- 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
- K141468: BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (2015), 2 descendants of its own

## Indications for use
The procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.

Source page: https://510kreport.com/device/K961623
Methodology: https://510kreport.com/methodology