Revumenib Eligibility Detection System

SFS · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1885

Classification

FDA Product Code: SFS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.1885
Review panel: PA
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown