# K933486: Fascount Systme

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Sep 9, 1994 after 417 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 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
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes (1997), 15 descendants of its own
- K970326: Tritest Reagent CD3 Fitc/CD8 PE/CD45 Percp;with Trucount Absolute Count Tubes (1997), 11 descendants of its own
- K970836: Trucount Absolute Count Tubes/Counting Control Beads (1997), 11 descendants of its own
- K974360: Multitest CD3/CD8/CD45/CD4 (1998), 10 descendants of its own
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution (1998), 5 descendants of its own

## Recalls of this device
- Jan 29, 2009 · Not classified · Z-1007-2010: The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.

Source page: https://510kreport.com/device/K933486
Methodology: https://510kreport.com/methodology