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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K201438
Device Name ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
Applicant
Arlington Scientific, Inc. (Asi)
1840 N. Technology Dr.
Springville,  UT  84663
Applicant Contact David Binks
Correspondent
Arlington Scientific, Inc. (Asi)
1840 N. Technology Dr.
Springville,  UT  84663
Correspondent Contact David Binks
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received06/01/2020
Decision Date 10/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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