# DEN040003: Glucatell

- Pathway: De Novo (Post-NSE)
- Applicant: Associates of Cape Cod, Inc.
- Decided: May 21, 2004 after 60 days
- Product code: NQZ (Antigen, Invasive Fungal Pathogens)
- Device class: 2
- Regulation: 21 CFR 866.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191167: Fungitell STAT (2019), 0 descendants of its own

Source page: https://510kreport.com/device/DEN040003
Methodology: https://510kreport.com/methodology