510(k) K201438

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer by Arlington Scientific, Inc. (Asi) — Product Code GMQ

K201438 is an FDA 510(k) premarket notification submitted by Arlington Scientific, Inc. (Asi) for the device "ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer". The FDA issued a decision of Substantially Equivalent on October 21, 2020. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Arlington Scientific, Inc. (Asi) has at least 2 other 510(k) clearances on record.