Documento fuente o registro público
FDA 510(k) K214023 — VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
FDA 510(k) index record K214023. Device: VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL). Applicant as listed: bioMerieux, Inc.. Decision date: 2022-04-14.
Fuente
"device_name": "VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?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.
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Automated FDA record verification
2026-10-20
2026-10-31
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FDA 510(k) public index record K214023.
Device name: VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL). Applicant as listed: bioMerieux, Inc..
Decision date: 2022-04-14. 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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