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FDA 510(k)

BioFire Warrior Panel; BioFire Warrior Panel Control Kit

K-Number: K243822 · 2025-03-12

ApplicantBiofire Defense, LLC
Decision Date2025-03-12
Product CodePRD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BioFire Warrior Panel; BioFire Warrior Panel Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K243822. The device is classified under product code PRD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioFire Warrior Panel; BioFire Warrior Panel Control Kit?

BioFire Warrior Panel; BioFire Warrior Panel Control Kit is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Biofire Defense, LLC. The 510(k) number is K243822.

When did BioFire Warrior Panel; BioFire Warrior Panel Control Kit receive FDA 510(k) clearance?

BioFire Warrior Panel; BioFire Warrior Panel Control Kit received FDA 510(k) clearance on 2025-03-12, under 510(k) number K243822.

Who is the listed applicant for BioFire Warrior Panel; BioFire Warrior Panel Control Kit?

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

What is the FDA product code for BioFire Warrior Panel; BioFire Warrior Panel Control Kit?

The FDA product code for BioFire Warrior Panel; BioFire Warrior Panel Control Kit is PRD.

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.

NCT07221097Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other CoronavirusesCOMPLETED

Other records listing Biofire Defense, LLC as applicant

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K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitK213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelK220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelK221460BioFire COVID-19 Test 2K211079BioFire COVID-19 Test 2K202382FilmArray Global Fever Panel External Control Kit

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Related Devices (Code: PRD)

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.

K170883FilmArray NGDS Warrior PanelBiofire Defense, 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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