K-number	K202977
Device name	Alinity m STI Assay
Applicant	Abbott Molecular, Inc.
Product code	QEP
Device class	Class II
Decision date	Apr 29, 2022
Decision	Substantially Equivalent
Regulation	866.3393

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Source

View the full FDA submission: accessdata.fda.gov

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Alinity m STI Assay

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