K-number	K231329
Device name	Aptima Neisseria gonorrhoeae Assay
Applicant	Hologic, Inc.
Product code	LSL
Device class	Class II
Decision date	Jan 26, 2024
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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Aptima Neisseria gonorrhoeae Assay

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