# K900802: Anti-Human Leu-3A (CD4) Fitc

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: May 15, 1990 after 84 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 27, 2015 · Class III · Z-2817-2015: CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

Source page: https://510kreport.com/device/K900802
Methodology: https://510kreport.com/methodology