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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 K964689
Device Name TRACCELL 2000 SLIDE MAPPING SYSTEM
Applicant
Accumed Intl., Inc.
900 # Franklin
Suite 401
Chicago,  IL  60610
Applicant Contact JOHN MIERS
Correspondent
Accumed Intl., Inc.
900 # Franklin
Suite 401
Chicago,  IL  60610
Correspondent Contact JOHN MIERS
Regulation Number864.5260
Classification Product Code
JOY  
Date Received11/22/1996
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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