510(k) DEN240067 ยท SFS Revumenib Eligibility Detection System
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
| Applicant | Cytocell Limited, Cambridge, GB |
| Decision | Unknown, Sep 19, 2025 |
| Received | Nov 22, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240067
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.