K-number	K233352
Device name	Aptima HCV Quant Dx Assay
Applicant	Hologic, Inc.
Product code	MZP
Device class	Class II
Decision date	Jul 24, 2024
Decision	Substantially Equivalent
Regulation	866.3170

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Source

View the full FDA submission: accessdata.fda.gov

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Aptima HCV Quant Dx Assay

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