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FDA 510(k)

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

K-Number: K230404 · 2023-03-16

ApplicantBiofire Diagnostics, LLC
Decision Date2023-03-16
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2023-03-16 under approval number K230404. 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?

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a medical device that received FDA 510(k) clearance on 2023-03-16. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K230404.

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

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel received FDA 510(k) clearance on 2023-03-16, under approval number K230404.

What company makes BIOFIRE FILMARRAY Gastrointestinal (GI) Panel?

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

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

The FDA product code for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel 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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