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

Name: FDA 510(k) clearance K150358
Creator: U.S. Food and Drug Administration
Published: 2015-11-12

Substantially Equivalent

Gold Standard Diagnostics

FDA 510(k) clearance K150358 for Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, Substantially Equivalent on 2015-11-12. Applicant: Gold Standard Diagnostics. Device class: 2.

Clearance details

Applicant: Gold Standard Diagnostics
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 2015-02-12
Decision date: 2015-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

Download summary PDF View on FDA.gov ↗

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