BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit— 510(k) K261475

Name: FDA 510(k) clearance K261475
Creator: U.S. Food and Drug Administration
Published: 2026-07-17

Substantially Equivalent

Biofire Defense, LLC

FDA 510(k) clearance K261475 for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit, Substantially Equivalent on 2026-07-17. Applicant: Biofire Defense, LLC. Device class: 2.

Clearance details

Applicant: Biofire Defense, LLC
Product code: Code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2026-05-05
Decision date: 2026-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PMN

view all

K260577 — FilmArray TF Control Panel M5272026-05-19
K260041 — MDx-Chex for BCP2026-03-27
K254166 — MDx-Chex for BCN2026-03-23
K254167 — MDx-Chex for BCY2026-03-17
K251526 — FilmArray GI Control Panel M2382025-08-14

More clearances from Biofire Defense, LLC

view all

K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit2025-03-12
K213362 — BioFire Global Fever Special Pathogens Panel +1 more2023-03-22
K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel2022-10-20
K221460 — BioFire COVID-19 Test 22022-07-25
K211079 — BioFire COVID-19 Test 22021-11-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.