Clearance Summary
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software received FDA 510(k) clearance under submission number K173492, sponsored by Molecularmd Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Medical Genetics review panel. The statutory decision date of record is 2017-12-22.
- Submission: K173492
- Applicant / Sponsor: Molecularmd Corporation
- Clearance pathway: Traditional
- Review panel: Medical Genetics
- Device class: Class II
- Regulation citation: 21 CFR 866.6060
- Decision date: 2017-12-22
Classification & Regulation
This clearance is catalogued under FDA product code OYX and 21 CFR 866.6060, within the Medical Genetics review panel as a Class II device.