BIOFIRE SPOTFIRE Respiratory (R) Panel— 510(k) K213954

Name: FDA 510(k) clearance K213954
Creator: U.S. Food and Drug Administration
Published: 2023-02-03

Substantially Equivalent

Biofire Diagnostics

FDA 510(k) clearance K213954 for BIOFIRE SPOTFIRE Respiratory (R) Panel, Substantially Equivalent on 2023-02-03. Applicant: Biofire Diagnostics. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2021-12-17
Decision date: 2023-02-03
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

view all

K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23

More clearances from Biofire Diagnostics

view all

K140407 — FILMARRAY GASTROINTESTINAL (GI) PANEL2014-05-02

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