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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microscope, automated, image analysis, operator intervention
510(k) Number K141109
Device Name APERIO EPATHOLOGY EIHC IVD SYSTEM
Applicant
LEICA BIOSYSTEMS IMAGING, INC.
1360 PARK CENTER DRIVE
VISTA,  CA  92081
Applicant Contact CHRISTINE KISHI
Correspondent
LEICA BIOSYSTEMS IMAGING, INC.
1360 PARK CENTER DRIVE
VISTA,  CA  92081
Correspondent Contact CHRISTINE KISHI
Regulation Number864.1860
Classification Product Code
NOT  
Subsequent Product Code
NQN  
Date Received04/29/2014
Decision Date 07/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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