Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System— 510(k) K250249

Name: FDA 510(k) clearance K250249
Creator: U.S. Food and Drug Administration
Published: 2025-10-10

Substantially Equivalent

Gold Standard Diagnostics, LLC

FDA 510(k) clearance K250249 for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, Substantially Equivalent on 2025-10-10. Applicant: Gold Standard Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Gold Standard Diagnostics, LLC
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 2025-01-27
Decision date: 2025-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

Download summary PDF View on FDA.gov ↗

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