ASI Automated RPR (rapid Plasma Reagin) Test For Syphilis, For Use On The ASI Evolution Automated Syphilis Analyzer

Antigens, Nontreponemal, All

Arlington Scientific, Inc. (ASI)

The following data is part of a premarket notification filed by Arlington Scientific, Inc. (asi) with the FDA for Asi Automated Rpr (rapid Plasma Reagin) Test For Syphilis, For Use On The Asi Evolution Automated Syphilis Analyzer.

Pre-market Notification Details

Device IDK201438
510k NumberK201438
Device Name:ASI Automated RPR (rapid Plasma Reagin) Test For Syphilis, For Use On The ASI Evolution Automated Syphilis Analyzer
ClassificationAntigens, Nontreponemal, All
Applicant Arlington Scientific, Inc. (ASI) 1840 North Technology Dr. Springville,  UT  84663
ContactDavid Binks
CorrespondentDavid Binks
Arlington Scientific, Inc. (ASI) 1840 North Technology Dr. Springville,  UT  84663
Product CodeGMQ  
CFR Regulation Number866.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-10-21

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