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FDA 510(k)

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

K-Number: K160459 · 2016-04-01

ApplicantBiofire Diagnostics, LLC
Decision Date2016-04-01
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-04-01 under approval number K160459. 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 FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch?

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K160459.

When was FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch approved by the FDA?

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch received FDA 510(k) clearance on 2016-04-01, under approval number K160459.

What company makes FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch?

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch?

The FDA product code for FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is PCH.

Related Clinical Trials

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Other Devices by Biofire Diagnostics, LLC

K152579FilmArray Respiratory Panel EZ (RP EZ) K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch K160068FilmArray Respiratory Panel (RP) for use with FilmArray Torch DEN170017FilmArray Respiratory Panel 2 plus (RP2plus) K170604FilmArray Respiratory Panel 2 (RP2)

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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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