510(k) K131330— GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

Substantially Equivalent

Gold Standard Diagnostics

Clearance details

Applicant: Gold Standard Diagnostics
Product code: Code LJM
Advisory panel: Immunology
Date received: 2013-05-08
Decision date: 2014-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

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