K-number	K152800
Device name	illumigene Mycoplasma DNA Amplification Assay
Applicant	Meridian Bioscience, Inc.
Product code	OZX
Device class	Class II
Decision date	Oct 23, 2015
Decision	Substantially Equivalent
Regulation	866.3980

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View the full FDA submission: accessdata.fda.gov

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illumigene Mycoplasma DNA Amplification Assay

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