510(k) K182391— ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

Substantially Equivalent

Arlington Scientific, Inc. (Asi)

Clearance details

Applicant: Arlington Scientific, Inc. (Asi)
Product code: Code GMQ
Advisory panel: Microbiology
Date received: 2018-09-04
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springville, UT, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.