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510(k) K243822

BioFire Warrior Panel; BioFire Warrior Panel Control Kit by Biofire Defense, LLC — Product Code PRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2025
Date Received
December 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Biofire Defense, LLC

  • 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)
  • DEN160048 — FilmArray NGDS Warrior Panel (February 14, 2017)

Other clearances for product code PRD

  • K170883 — FilmArray NGDS Warrior Panel (June 22, 2017)
  • DEN160048 — FilmArray NGDS Warrior Panel (February 14, 2017)