K252243
- 510(k) number
- K252243
- Device name
- Fastplex BCR-ABL (p210) %IS digital PCR Kit
- Applicant
- Suzhou Precigenome, Ltd. Co; CN
- Product code
- OYX — Bcr/Abl1 Monitoring Test
- Decision date
- 2026-07-02
- Date received
- 2025-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Medical Genetics
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K252243.pdf
Official FDA record: K252243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.