# K946055: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Feb 20, 1996 after 449 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.
14 later devices descend from it; 2 cite it directly.
0 of 15 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
- K963963: Multiset Software for Automated Flow Cytometric Data Analysis (1996), 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
- K060375: BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 (2006), 3 descendants of its own
- K090967: BD Multitest 6-Color TBNK Reagent, Model 644611 (2009), 2 descendants of its own

## Recalls of this device
- Sep 7, 2007 · Not classified · Z-1845-2011: Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.

Source page: https://510kreport.com/device/K946055
Methodology: https://510kreport.com/methodology