Source document or public record
FDA 510(k) K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
FDA 510(k) index record K251713. Device: BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL). Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-08-08.
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"device_name": "BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K251713.
Device name: BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL). Applicant as listed: Becton, Dickinson and Company.
Decision date: 2025-08-08. 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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