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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
510(k) Number K122554
Device Name GENASIS SCANVIEW SYSTEM
Original Applicant
APPLIED SPECTRAL IMAGING, LTD.
a-109 neto- golf
caesarea,  IS 30889
Original Contact ilan sharon
Regulation Number866.4700
Classification Product Code
NTH  
Date Received08/21/2012
Decision Date 02/07/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01620853
Reviewed by Third Party No
Expedited Review No
Combination Product No
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