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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 K111356
Device Name ASIMANAGER - AT
Original Applicant
ARLINGTON SCIENTIFIC, INC.
1840 north technology dr.
springville,  UT  84663
Original Contact david binks
Regulation Number862.2400
Classification Product Code
JQT  
Date Received05/16/2011
Decision Date 11/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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