Documento fuente o registro público
FDA 510(k) K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
FDA 510(k) index record K260447. Device: ETEST Gepotidacin (GEP) (0.016-256 µg/mL). Applicant as listed: bioMérieux SA. Decision date: 2026-04-21.
Fuente
"device_name": "ETEST Gepotidacin (GEP) (0.016-256 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
2026-10-23
professional use
FDA 510(k) public index record K260447.
Device name: ETEST Gepotidacin (GEP) (0.016-256 µg/mL). Applicant as listed: bioMérieux SA.
Decision date: 2026-04-21. Decision wording: Substantially Equivalent.
Product code: JWY. Regulation: 21 CFR 866.1640. 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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