K-number	K182559
Device name	PREMIER Platinum HpSA PLUS
Applicant	Meridian Bioscience, Inc.
Product code	LYR
Device class	Class I
Decision date	Nov 5, 2018
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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PREMIER Platinum HpSA PLUS

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