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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 the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2023-03-16 under 510(k) 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. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K230404.

When did BIOFIRE FILMARRAY Gastrointestinal (GI) Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel?

The FDA 510(k) record lists Biofire Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Biofire Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniK243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelK241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniK232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

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Related Devices (Code: PCH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther Fusion GI Bacterial AssayHologic

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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