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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 K080910
Device Name PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
Applicant
Bioimagene, Inc.
1601 S. De Anza Blvd.
Suite 212
Cupertino,  CA  95014
Applicant Contact INDU LAKSHMAN
Correspondent
Bioimagene, Inc.
1601 S. De Anza Blvd.
Suite 212
Cupertino,  CA  95014
Correspondent Contact INDU LAKSHMAN
Regulation Number864.1860
Classification Product Code
NOT  
Date Received04/01/2008
Decision Date 02/04/2009
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
Predetermined Change
Control Plan Authorized		 No
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