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FDA 510(k)

BIOFIRE SPOTFIRE Respiratory (R) Panel

K-Number: K213954 · 2023-02-03

ApplicantBiofire Diagnostics
Decision Date2023-02-03
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE SPOTFIRE Respiratory (R) Panel is a medical device manufactured by Biofire Diagnostics. It received FDA 510(k) clearance on 2023-02-03 under approval number K213954. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE SPOTFIRE Respiratory (R) Panel?

BIOFIRE SPOTFIRE Respiratory (R) Panel is a medical device that received FDA 510(k) clearance on 2023-02-03. It is manufactured by Biofire Diagnostics. The 510(k) number is K213954.

When was BIOFIRE SPOTFIRE Respiratory (R) Panel approved by the FDA?

BIOFIRE SPOTFIRE Respiratory (R) Panel received FDA 510(k) clearance on 2023-02-03, under approval number K213954.

What company makes BIOFIRE SPOTFIRE Respiratory (R) Panel?

BIOFIRE SPOTFIRE Respiratory (R) Panel is manufactured by Biofire Diagnostics.

What is the FDA product code for BIOFIRE SPOTFIRE Respiratory (R) Panel?

The FDA product code for BIOFIRE SPOTFIRE Respiratory (R) Panel is QOF.

Related Clinical Trials

NCT07513519 Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial RECRUITING

Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC

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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