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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica
510(k) Number BK140192
Tradename ASi Manager-AT
Device Name Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Original Applicant
Arlington Scientific, Inc.
1840 north technology dr.
springville,  UT  84663
Regulation Number862.2400
Classification Product Code
JQT  
Date Received11/12/2014
Decision Date 02/19/2015
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
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 No
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