Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-10-03 under 510(k) 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. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K152579.

When did FilmArray Respiratory Panel EZ (RP EZ) receive FDA 510(k) clearance?

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

Who is the listed applicant for FilmArray Respiratory Panel EZ (RP EZ)?

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 EZ (RP EZ)?

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

View all 21 devices →

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.

↑