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FDA 510(k)

FilmArray Respiratory Panel EZ (RP EZ)

K-Number: K152579 · 2016-10-03

ApplicantBiofire Diagnostics, LLC
Decision Date2016-10-03
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Respiratory Panel EZ (RP EZ) is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-10-03 under approval number K152579. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FilmArray Respiratory Panel EZ (RP EZ)?

FilmArray Respiratory Panel EZ (RP EZ) is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K152579.

When was FilmArray Respiratory Panel EZ (RP EZ) approved by the FDA?

FilmArray Respiratory Panel EZ (RP EZ) received FDA 510(k) clearance on 2016-10-03, under approval number K152579.

What company makes FilmArray Respiratory Panel EZ (RP EZ)?

FilmArray Respiratory Panel EZ (RP EZ) is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Respiratory Panel EZ (RP EZ)?

The FDA product code for FilmArray Respiratory Panel EZ (RP EZ) is OCC.

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Related Devices (Code: OCC)

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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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