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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name antigens, nontreponemal, all
510(k) Number BK200539
Tradename ASI Automated RPR test for Syphilis for use on the ASI Evolution
Device Name Antigens, Nontreponemal, All
Original Applicant
Arlington Scientific, Inc.
1840 north technology dr.
springville,  UT  84663
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received11/05/2020
Decision Date 02/02/2021
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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