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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 K031715
Device Name ARIOL HER-2/NEU IHC
Applicant
Applied Imaging Corp.
2380 Walsh Ave., Bldg.B
Santa Clara,  CA  95051
Applicant Contact DIANE C OATES
Correspondent
Applied Imaging Corp.
2380 Walsh Ave., Bldg.B
Santa Clara,  CA  95051
Correspondent Contact DIANE C OATES
Regulation Number864.1860
Classification Product Code
NOT  
Date Received06/02/2003
Decision Date 01/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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