Name: Predicase
Price: 199 USD

K-number	K243222
Device name	BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
Applicant	Biofire Diagnostics, LLC (Biomerieux)
Product code	QDS
Device class	Class II
Decision date	Nov 6, 2024
Decision	Substantially Equivalent
Regulation	866.4001

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Source

View the full FDA submission: accessdata.fda.gov

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BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

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