Antigens, Nontreponemal, All

Antigens, Nontreponemal, All

Arlington Scientific, Inc.

The following data is part of a premarket notification filed by Arlington Scientific, Inc. with the FDA for Antigens, Nontreponemal, All.

Pre-market Notification Details

Device IDBK200488
510k NumberBK200488
Device Name:Antigens, Nontreponemal, All
ClassificationAntigens, Nontreponemal, All
Applicant Arlington Scientific, Inc. 1840 North Technology Dr. Springville,  UT  84663
Product CodeGMQ  
CFR Regulation Number866.3820 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2020-09-30

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