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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 K130775
Device Name DUET SYSTEM
Applicant
BIOVIEW LTD.
25A SIRKIN ST.
kfar saba,  IL 44421
Applicant Contact orly maor
Correspondent
BIOVIEW LTD.
25A SIRKIN ST.
kfar saba,  IL 44421
Correspondent Contact orly maor
Regulation Number866.4700
Classification Product Code
NTH  
Subsequent Product Code
JOY  
Date Received03/20/2013
Decision Date 05/09/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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