Source document or public record
FDA 510(k) K230827 — HardyDisk AST Rezafungin 5µg (RZF5)
FDA 510(k) index record K230827. Device: HardyDisk AST Rezafungin 5µg (RZF5). Applicant as listed: Hardy Diagnostics. Decision date: 2023-06-01.
Source
"device_name": "HardyDisk AST Rezafungin 5µg (RZF5)"
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 K230827.
Device name: HardyDisk AST Rezafungin 5µg (RZF5). Applicant as listed: Hardy Diagnostics.
Decision date: 2023-06-01. 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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