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FDA 510(k)

FILMARRAY RESPIRATORY PANEL (RP)

K-Number: K123620 · 2013-02-11

ApplicantBiofire Diagnostics, Inc.
Decision Date2013-02-11
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FILMARRAY RESPIRATORY PANEL (RP) is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-02-11 under 510(k) number K123620. 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)?

FILMARRAY RESPIRATORY PANEL (RP) is a medical device that received FDA 510(k) clearance on 2013-02-11. The listed applicant is Biofire Diagnostics, Inc.. The 510(k) number is K123620.

When did FILMARRAY RESPIRATORY PANEL (RP) receive FDA 510(k) clearance?

FILMARRAY RESPIRATORY PANEL (RP) received FDA 510(k) clearance on 2013-02-11, under 510(k) number K123620.

Who is the listed applicant for FILMARRAY RESPIRATORY PANEL (RP)?

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

What is the FDA product code for FILMARRAY RESPIRATORY PANEL (RP)?

The FDA product code for FILMARRAY RESPIRATORY PANEL (RP) is OCC.

Related Clinical Trials

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Other records listing Biofire Diagnostics, Inc. 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.

K131930JBAIDS ANTHRAX DETECTION KITK131729JBAIDS PLAGUE DETECTION KITK131936JBAIDS TULAREMIA DETECTION KITK130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

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.

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.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.

Official Source

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