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510(k) K141109

APERIO EPATHOLOGY EIHC IVD SYSTEM by Leica Biosystems Imaging, Inc. — Product Code NOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2014
Date Received
April 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Operator Intervention
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.

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