SFSClass II
Revumenib Eligibility Detection System
21 CFR 864.1885 / Hematology
SFS is the FDA product code for Revumenib Eligibility Detection System, a class II device type, regulated under 21 CFR 864.1885. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SFS
- Device name
- Revumenib Eligibility Detection System
- 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.
- Regulation
- 21 CFR 864.1885
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SFS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SFS| Applicant | Clearances |
|---|---|
| Cytocell Limited | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.