Documento fuente o registro público
FDA 510(k) K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
FDA 510(k) index record K250447. Device: BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL). Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-05-19.
Fuente
"device_name": "BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-25
professional use
FDA 510(k) public index record K250447.
Device name: BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL). Applicant as listed: Becton, Dickinson and Company.
Decision date: 2025-05-19. Decision wording: Substantially Equivalent.
Product code: LON. Regulation: 21 CFR 866.1645. 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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