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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 the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2017-05-30 under 510(k) 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. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K170604.

When did FilmArray Respiratory Panel 2 (RP2) receive FDA 510(k) clearance?

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

Who is the listed applicant for FilmArray Respiratory Panel 2 (RP2)?

The FDA 510(k) record lists Biofire Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Biofire Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniK243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelK241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniK232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

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Related Devices (Code: OCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, 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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