K250249

Substantially Equivalent

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Applicant: Gold Standard Diagnostics, LLC
Product code: GMQ
Advisory panel: Microbiology
Date received: 2025-01-27
Decision date: 2025-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

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