K-number	K190515
Device name	Aptima Combo 2 Assay (Panther System)
Applicant	Hologic, Inc.
Product code	QEP
Device class	Class II
Decision date	May 23, 2019
Decision	Substantially Equivalent
Regulation	866.3393

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View the full FDA submission: accessdata.fda.gov

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Aptima Combo 2 Assay (Panther System)

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