K-number	K221869
Device name	BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Applicant	Suzhou Sniper Medical Technologies Co., Ltd.
Product code	OYX
Device class	Class II
Decision date	Sep 5, 2023
Decision	Substantially Equivalent
Regulation	866.6060

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Source

View the full FDA submission: accessdata.fda.gov

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BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

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