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FDA 510(k)

FilmArray Respiratory Panel (RP) for use with FilmArray Torch

K-Number: K160068 · 2016-02-08

ApplicantBiofire Diagnostics, LLC
Decision Date2016-02-08
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Respiratory Panel (RP) for use with FilmArray Torch is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-02-08 under approval number K160068. 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 (RP) for use with FilmArray Torch?

FilmArray Respiratory Panel (RP) for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-02-08. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K160068.

When was FilmArray Respiratory Panel (RP) for use with FilmArray Torch approved by the FDA?

FilmArray Respiratory Panel (RP) for use with FilmArray Torch received FDA 510(k) clearance on 2016-02-08, under approval number K160068.

What company makes FilmArray Respiratory Panel (RP) for use with FilmArray Torch?

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

What is the FDA product code for FilmArray Respiratory Panel (RP) for use with FilmArray Torch?

The FDA product code for FilmArray Respiratory Panel (RP) for use with FilmArray Torch is OCC.

Other Devices by Biofire Diagnostics, LLC

K152579FilmArray Respiratory Panel EZ (RP EZ) K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch DEN170017FilmArray Respiratory Panel 2 plus (RP2plus) K170604FilmArray Respiratory Panel 2 (RP2)

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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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