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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemistry Antibody Assay, Estrogen Receptor
510(k) Number K012138
Device Name MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
Applicant
Chroma Vision Medical Systems, Inc.
33171 Paseo Cerveza
San Juan Capistrano,  CA  92675
Applicant Contact DAVID DAVIS
Correspondent
Chroma Vision Medical Systems, Inc.
33171 Paseo Cerveza
San Juan Capistrano,  CA  92675
Correspondent Contact DAVID DAVIS
Regulation Number864.1860
Classification Product Code
MYA  
Subsequent Product Code
MXZ  
Date Received07/10/2001
Decision Date 09/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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