Source document or public record
FDA 510(k) K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
FDA 510(k) index record K232954. Device: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2024-03-26.
Source
"device_name": "BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K232954.
Device name: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel. Applicant as listed: Biofire Diagnostics, LLC.
Decision date: 2024-03-26. Decision wording: Substantially Equivalent.
Product code: QOF. Regulation: 21 CFR 866.3981. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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