Panels › Hematology › Product code SFS · Class 2
Revumenib Eligibility Detection System
Regulation 864.1885
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytocell Limited | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 2025 | DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) Cytocell Limited, GB | SFS |
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