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FDA 510(k)

FilmArray NGDS Warrior Panel

K-Number: K170883 · 2017-06-22

ApplicantBiofire Defense, LLC
Decision Date2017-06-22
Product CodePRD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FilmArray NGDS Warrior Panel 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 2017-06-22 under 510(k) number K170883. 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 FilmArray NGDS Warrior Panel?

FilmArray NGDS Warrior Panel is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Biofire Defense, LLC. The 510(k) number is K170883.

When did FilmArray NGDS Warrior Panel receive FDA 510(k) clearance?

FilmArray NGDS Warrior Panel received FDA 510(k) clearance on 2017-06-22, under 510(k) number K170883.

Who is the listed applicant for FilmArray NGDS Warrior Panel?

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 FilmArray NGDS Warrior Panel?

The FDA product code for FilmArray NGDS Warrior Panel 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

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.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitK243822BioFire Warrior Panel; BioFire Warrior 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 2

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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.

K243822BioFire Warrior Panel; BioFire Warrior Panel Control KitBiofire 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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