Source document or public record
FDA 510(k) K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
FDA 510(k) index record K250856. Device: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL). Applicant as listed: Biomérieux. Decision date: 2025-06-12.
Source
"device_name": "ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K250856.
Device name: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL). Applicant as listed: Biomérieux.
Decision date: 2025-06-12. 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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