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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K984188
Device Name AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
Applicant
Chroma Vision Medical Systems, Inc.
3535 Firewheel Dr.
Suite A
Flower Mound,  TX  75028 -2628
Applicant Contact BERTRAM J HUDSON
Correspondent
Chroma Vision Medical Systems, Inc.
3535 Firewheel Dr.
Suite A
Flower Mound,  TX  75028 -2628
Correspondent Contact BERTRAM J HUDSON
Regulation Number864.5260
Classification Product Code
JOY  
Date Received11/23/1998
Decision Date 07/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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