Documento fuente o registro público
FDA 510(k) K192665 — Accelerate Pheno System, Accelerate PhenoTest BC Kit
FDA 510(k) index record K192665. Device: Accelerate Pheno System, Accelerate PhenoTest BC Kit. Applicant as listed: Accelerate Diagnostics, Inc.. Decision date: 2020-09-15.
Fuente
"device_name": "Accelerate Pheno System, Accelerate PhenoTest BC Kit"
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 K192665.
Device name: Accelerate Pheno System, Accelerate PhenoTest BC Kit. Applicant as listed: Accelerate Diagnostics, Inc..
Decision date: 2020-09-15. Decision wording: Substantially Equivalent.
Product code: PRH. Regulation: 21 CFR 866.1650. 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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