Class Class II

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404)

K230404 2023-03-16 Special
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Description

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel by Biofire Diagnostics, LLC — FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230404
Clearance Date2023-03-16
Clearance TypeSpecial
Product CodePCH
Regulation Number866.3990

Categories

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