Clearance Summary
Fastplex BCR-ABL (p210) %IS digital PCR Kit received FDA 510(k) clearance under submission number K252243, sponsored by Suzhou Precigenome, Ltd. Co;. 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 2026-07-02.
- Submission: K252243
- Applicant / Sponsor: Suzhou Precigenome, Ltd. Co;
- Clearance pathway: Traditional
- Review panel: Medical Genetics
- Device class: Class II
- Regulation citation: 21 CFR 866.6060
- Decision date: 2026-07-02
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.