Name: Predicase
Price: 199 USD

K-number	K133673
Device name	ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
Applicant	Meridian Bioscience, Inc.
Product code	OZZ
Device class	Class II
Decision date	Mar 25, 2014
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA

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