Name: Predicase
Price: 199 USD

K-number	K123905
Device name	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant	Centers for Disease Control and Prevention
Product code	OQW
Device class	Class II
Decision date	Jan 14, 2013
Decision	Substantially Equivalent
Regulation	866.3332

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

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