FDA product code SFS: Revumenib Eligibility Detection System
SFS is the FDA product code for revumenib eligibility detection system. It is a Class II device, regulated under 21 CFR 864.1885 and reviewed by the Pathology panel. Devices under SFS reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Revumenib Eligibility Detection System |
| Device class | Class II |
| Regulation | 21 CFR 864.1885 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for SFS devices
openFDA lists no recalls for product code SFS.
Frequently asked questions
What is FDA product code SFS?
SFS is the FDA product code for revumenib eligibility detection system. It is a Class II device, regulated under 21 CFR 864.1885 and reviewed by the Pathology panel.
What device class is SFS?
Class II, regulation 21 CFR 864.1885. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SFS
- Run a recall and safety report across every SFS manufacturer
- Watch product code SFS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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