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510(k) DEN160048

FilmArray NGDS Warrior Panel by Biofire Defense, LLC — Product Code PRD

DEN160048 is an FDA 510(k) premarket notification submitted by Biofire Defense, LLC for the device "FilmArray NGDS Warrior Panel". The FDA issued a decision of De Novo Granted on February 14, 2017. Biofire Defense, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 14, 2017
Date Received
October 17, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Other clearances by Biofire Defense, LLC

  • K261475 — BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (July 17, 2026)
  • K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (March 12, 2025)
  • K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the (March 22, 2023)
  • K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fe (October 20, 2022)
  • K221460 — BioFire COVID-19 Test 2 (July 25, 2022)
  • K211079 — BioFire COVID-19 Test 2 (November 1, 2021)
  • K202382 — FilmArray Global Fever Panel External Control Kit (November 20, 2020)
  • DEN200043 — FilmArray Global Fever Panel (November 20, 2020)
  • K170883 — FilmArray NGDS Warrior Panel (June 22, 2017)

Other clearances for product code PRD

  • K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (March 12, 2025)
  • K170883 — FilmArray NGDS Warrior Panel (June 22, 2017)

FDA data resources