K201438

Substantially Equivalent

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

Applicant: Arlington Scientific, Inc. (Asi)
Product code: GMQ
Advisory panel: Microbiology
Date received: 2020-06-01
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springville, UT, US

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