FDA applicant
Cytocell Limited
FDA records 2 decisions for Cytocell Limited (Cambridge, GB) from 2018 to 2025: 2 De Novo grants. Most are in product codes SFS (Revumenib Eligibility Detection System) and QDI (Fish Based Detection Of Chromosomal…). No recall is linked to its devices.
FDA’s records also spell it “Cytocell, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cytocell Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Cytocell Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report