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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
Applicant
ARLINGTON SCIENTIFIC, INC.
1840 north technology dr.
springville,  UT  84663
Applicant Contact david binks
Correspondent
ARLINGTON SCIENTIFIC, INC.
1840 north technology dr.
springville,  UT  84663
Correspodent 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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