BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel— 510(k) K232954

Name: FDA 510(k) clearance K232954
Creator: U.S. Food and Drug Administration
Published: 2024-03-26

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K232954 for BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, Substantially Equivalent on 2024-03-26. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2023-09-21
Decision date: 2024-03-26
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K232954

K-number listed on FDA's recall record

Z-2081-2026 — Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485Class II·Ongoing·BioFire Diagnostics, LLC·20260401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232954.

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