ASI Automated ASI RPR Test For Syphilis On The ASI Evolution

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 Asi Rpr Test For Syphilis On The Asi Evolution.

Pre-market Notification Details

Device IDK182391
510k NumberK182391
Device Name:ASI Automated ASI RPR Test For Syphilis On The ASI Evolution
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 Received2018-09-04
Decision Date2018-11-30
Summary:summary

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