510(k) K221869— BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

Substantially Equivalent

Suzhou Sniper Medical Technologies Co., Ltd.

Clearance details

Applicant: Suzhou Sniper Medical Technologies Co., Ltd.
Product code: Code OYX
Advisory panel: Medical Genetics
Date received: 2022-06-28
Decision date: 2023-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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