Name: Predicase
Price: 199 USD

K-number	K181736
Device name	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
Applicant	Centers For Disease Control and Prevention (CDC)
Product code	OZE
Device class	Class II
Decision date	Jul 30, 2018
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 B Lineage Genotyping Kit,

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