Source document or public record
FDA 510(k) K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)
FDA 510(k) index record K260842. Device: HardyDisk AST Gepotidacin 10µg (GEP10). Applicant as listed: Hardy Diagnostics. Decision date: 2026-05-11.
Source
"device_name": "HardyDisk AST Gepotidacin 10µg (GEP10)"
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
professional use
FDA 510(k) public index record K260842.
Device name: HardyDisk AST Gepotidacin 10µg (GEP10). Applicant as listed: Hardy Diagnostics.
Decision date: 2026-05-11. 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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