Documento fuente o registro público
FDA 510(k) K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
FDA 510(k) index record K230719. Device: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2023-04-13.
Fuente
"device_name": "BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K230719.
Device name: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. Applicant as listed: Biofire Diagnostics, LLC.
Decision date: 2023-04-13. 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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