Source document or public record
FDA 510(k) K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k) index record K250249. Device: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System. Applicant as listed: Gold Standard Diagnostics, LLC. Decision date: 2025-10-10.
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"device_name": "Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K250249.
Device name: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System. Applicant as listed: Gold Standard Diagnostics, LLC.
Decision date: 2025-10-10. Decision wording: Substantially Equivalent.
Product code: GMQ. Regulation: 21 CFR 866.3820. 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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