Name: Predicase
Price: 199 USD

K-number	K160829
Device name	illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
Applicant	Meridian Bioscience, Inc.
Product code	OZX
Device class	Class II
Decision date	Jun 13, 2016
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

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