SFS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Revumenib Eligibility Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1885
- Medical specialty
- Hematology
- FDA definition
- A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the purpose of identifying patients who may benefit from treatment with revumenib, in accordance with the approved therapeutic product labeling.
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| Record | Firm | Date |
|---|---|---|
| KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (DEN240067) | Cytocell Limited | 2025-09-19 |
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Every clearance here is in the API, with alerts when new ones post.