Name: Predicase
Price: 199 USD

K-number	K241110
Device name	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
Applicant	Centers for Disease Control and Prevention
Product code	OZE
Device class	Class II
Decision date	May 21, 2024
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 (Ver4)

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