510(k) K252243— Fastplex BCR-ABL (p210) %IS digital PCR Kit

Substantially Equivalent

Suzhou Precigenome, Ltd. Co;

Clearance details

Applicant: Suzhou Precigenome, Ltd. Co;
Product code: Code OYX
Advisory panel: Medical Genetics
Date received: 2025-07-18
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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