Class Class II

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (K243222)

K243222 2024-11-06 Special
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Description

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) by Biofire Diagnostics, LLC (Biomerieux) — FDA 510(k) cleared pathology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243222
Clearance Date2024-11-06
Clearance TypeSpecial
Product CodeQDS
Regulation Number866.4001

Categories

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