# Cytocell Limited

- Location (FDA's records): Cambridge, GB
- FDA decisions: 2 (2018–2025): 2 De Novo grants
- Names in FDA's records: Cytocell Limited (1); Cytocell, Ltd. (1)
- Product codes: SFS (1), QDI (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- DEN240067: KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (Sep 19, 2025)
- DEN170070: MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del (20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del (5q)Deletion FISH Probe Kit; Del (7q)Deletion FISH Probe Kit (Dec 21, 2018)

Source page: https://510kreport.com/company/cytocell