Name: Predicase
Price: 199 USD

K-number	K140857
Device name	INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant	Centers for Disease Control and Prevention
Product code	OZE
Device class	Class II
Decision date	Apr 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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INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

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