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FDA 510(k)

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

K-Number: K243885 · 2025-01-16

ApplicantBiofire Diagnostics, LLC
Decision Date2025-01-16
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2025-01-16 under approval number K243885. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K243885.

When was BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid approved by the FDA?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid received FDA 510(k) clearance on 2025-01-16, under approval number K243885.

What company makes BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid?

The FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid is PCH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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