K-number	K203833
Device name	Tacrolimus Assay Kit
Applicant	Shanghai Genext Medical Technology Co., Ltd.
Product code	MLM
Device class	Class II
Decision date	Jan 27, 2023
Decision	Substantially Equivalent
Regulation	862.1678

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Source

View the full FDA submission: accessdata.fda.gov

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Tacrolimus Assay Kit

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