Name: Predicase
Price: 199 USD

K-number	K153148
Device name	CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
Applicant	Centers For Disease Control and Prevention (CDC)
Product code	OZE
Device class	Class II
Decision date	Dec 1, 2015
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/H5 Subtyping

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