K-number	K222736
Device name	Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Applicant	Hologic, Inc.
Product code	QOF
Device class	Class II
Decision date	May 16, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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View the full FDA submission: accessdata.fda.gov

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Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

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