Name: Predicase
Price: 199 USD

K-number	K161556
Device name	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
Applicant	Centers For Disease Control and Prevention (CDC)
Product code	OZE
Device class	Class II
Decision date	Jun 30, 2016
Decision	Substantially Equivalent
Regulation	866.3980

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

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