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FDA 510(k)

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

K-Number: K243544 · 2025-08-14

ApplicantBiofire Diagnostics, LLC
Decision Date2025-08-14
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini 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 2025-08-14 under 510(k) number K243544. 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/Sore Throat Panel Mini?

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K243544.

When did BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini receive FDA 510(k) clearance?

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini received FDA 510(k) clearance on 2025-08-14, under 510(k) number K243544.

Who is the listed applicant for BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini?

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 BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini?

The FDA product code for BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini is QOF.

Related Clinical Trials

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.

NCT00448981Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy TrialCOMPLETEDNCT07678086Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic AppendectomyRECRUITING

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.

K243885BIOFIRE 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) PanelK230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

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Related Devices (Code: QOF)

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.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

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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