Documento fuente o registro público
FDA 510(k) K200512 — ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
FDA 510(k) index record K200512. Device: ETEST Plazomicin (PLZ) (0.016-256 µg/mL). Applicant as listed: Biomérieux SA. Decision date: 2020-05-07.
Fuente
"device_name": "ETEST Plazomicin (PLZ) (0.016-256 µg/mL)"
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K200512.
Device name: ETEST Plazomicin (PLZ) (0.016-256 µg/mL). Applicant as listed: Biomérieux SA.
Decision date: 2020-05-07. 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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