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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 K032113
Device Name 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
NOT  
Date Received07/09/2003
Decision Date 12/23/2003
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
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