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FDA 510(k)

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

K-Number: K160462 · 2016-03-17

ApplicantBiofire Diagnostics, LLC
Decision Date2016-03-17
Product CodePLO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-03-17 under approval number K160462. The device is classified under product code PLO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch?

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K160462.

When was FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch approved by the FDA?

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch received FDA 510(k) clearance on 2016-03-17, under approval number K160462.

What company makes FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch?

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch?

The FDA product code for FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch is PLO.

Other Devices by Biofire Diagnostics, LLC

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Related Devices (Code: PLO)

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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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