Home / 510(k) Clearances / K170883

510(k) K170883

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

K170883 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 Substantially Equivalent on June 22, 2017. Biofire Defense, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2017
Date Received
March 24, 2017
Clearance Type
Traditional
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)
  • DEN160048 — FilmArray NGDS Warrior Panel (February 14, 2017)

Other clearances for product code PRD

  • K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (March 12, 2025)
  • DEN160048 — FilmArray NGDS Warrior Panel (February 14, 2017)

FDA data resources