Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Biofire Defense, LLC. It received FDA 510(k) clearance on 2017-06-22 under approval 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. It is manufactured by Biofire Defense, LLC. The 510(k) number is K170883.

When was FilmArray NGDS Warrior Panel approved by the FDA?

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

What company makes FilmArray NGDS Warrior Panel?

FilmArray NGDS Warrior Panel is manufactured by Biofire Defense, LLC.

What is the FDA product code for FilmArray NGDS Warrior Panel?

The FDA product code for FilmArray NGDS Warrior Panel is PRD.

Other Devices by Biofire Defense, LLC

DEN160048FilmArray NGDS Warrior Panel DEN200043FilmArray Global Fever Panel K202382FilmArray Global Fever Panel External Control Kit K211079BioFire COVID-19 Test 2 K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel K221460BioFire COVID-19 Test 2

View all 9 devices →

Related Devices (Code: PRD)

DEN160048FilmArray NGDS Warrior PanelBiofire Defense, LLC 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.

↑