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FDA 510(k)

FilmArray Respiratory Panel 2 (RP2)

K-Number: K170604 · 2017-05-30

ApplicantBiofire Diagnostics, LLC
Decision Date2017-05-30
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Respiratory Panel 2 (RP2) is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2017-05-30 under approval number K170604. 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 2 (RP2)?

FilmArray Respiratory Panel 2 (RP2) is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K170604.

When was FilmArray Respiratory Panel 2 (RP2) approved by the FDA?

FilmArray Respiratory Panel 2 (RP2) received FDA 510(k) clearance on 2017-05-30, under approval number K170604.

What company makes FilmArray Respiratory Panel 2 (RP2)?

FilmArray Respiratory Panel 2 (RP2) is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Respiratory Panel 2 (RP2)?

The FDA product code for FilmArray Respiratory Panel 2 (RP2) is OCC.

Other Devices by Biofire Diagnostics, LLC

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Related Devices (Code: OCC)

K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. K152579FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC K161814Solana Influenza A+B AssayQuidel Corporation K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. K161220ARIES® Flu A/B & RSV AssayLuminex Corporation K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.

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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