Documento fuente o registro público
FDA 510(k) K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
FDA 510(k) index record K232395. Device: ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD. Applicant as listed: Biomérieux. Decision date: 2023-10-05.
Fuente
"device_name": "ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K232395.
Device name: ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD. Applicant as listed: Biomérieux.
Decision date: 2023-10-05. 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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