Name: Predicase
Price: 199 USD

K-number	K123423
Device name	ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
Applicant	Meridian Bioscience, Inc.
Product code	OZX
Device class	Class II
Decision date	Jun 5, 2013
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

Everything you need for a 510(k) submission. Nothing you don't.