FDA Product Code SFS: Revumenib Eligibility Detection System
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.
Leading manufacturers include Cytocell Limited.
FDA 510(k) Cleared Revumenib Eligibility Detection System Devices (Product Code SFS)
About Product Code SFS - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFS since 2025, with 0 receiving FDA clearance (average review time: 301 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFS devices are reviewed by the Medical Genetics panel. Browse all Medical Genetics devices →