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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 K101291
Device Name SCANVIEW HER2/NEU FISH SYSTEM
Applicant
Applied Spectral Imaging , Ltd.
6 Sireni
Haifa,  IL 32972
Applicant Contact DAN LAOR
Correspondent
Applied Spectral Imaging , Ltd.
6 Sireni
Haifa,  IL 32972
Correspondent Contact DAN LAOR
Regulation Number866.4700
Classification Product Code
NTH  
Date Received05/07/2010
Decision Date 11/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01066507
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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