K-number	K132251
Device name	APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
Applicant	Hologic / Gen-Probe Incorporated
Product code	LSL
Device class	Class II
Decision date	Oct 17, 2013
Decision	Substantially Equivalent
Regulation	866.3390

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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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