510(k) K150358— Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Substantially Equivalent

Gold Standard Diagnostics

Clearance details

Applicant: Gold Standard Diagnostics
Product code: Code GMQ
Advisory panel: Microbiology
Date received: 2015-02-12
Decision date: 2015-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

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