Name: Predicase
Price: 199 USD

K-number	K182619
Device name	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Applicant	Genmark Diagnostics, Incorporated
Product code	PEN
Device class	Class II
Decision date	Apr 12, 2019
Decision	Substantially Equivalent
Regulation	866.3365

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Source

View the full FDA submission: accessdata.fda.gov

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ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

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