Source document or public record
FDA 510(k) K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
FDA 510(k) index record K250454. Device: HardyDisk Aztreonam/Avibactam 30/20µg (AZA50). Applicant as listed: Hardy Diagnostics. Decision date: 2025-05-15.
Source
"device_name": "HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)"
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 K250454.
Device name: HardyDisk Aztreonam/Avibactam 30/20µg (AZA50). Applicant as listed: Hardy Diagnostics.
Decision date: 2025-05-15. Decision wording: Substantially Equivalent.
Product code: JTN. Regulation: 21 CFR 866.1620. 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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