K-number	K203184
Device name	HYDRASHIFT 2/4 isatuximab
Applicant	Sebia
Product code	CFF
Device class	Class II
Decision date	Nov 12, 2021
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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HYDRASHIFT 2/4 isatuximab

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