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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 K982786
Device Name TRACCELL 2000 SLIDE MAPPING SYSTEM
Applicant
Accumed Intl., Inc.
900 # Franklin
Suite 401
Chicago,  IL  60610
Applicant Contact NORMAN J PRESSMAN
Correspondent
Accumed Intl., Inc.
900 # Franklin
Suite 401
Chicago,  IL  60610
Correspondent Contact NORMAN J PRESSMAN
Regulation Number864.5260
Classification Product Code
JOY  
Date Received08/10/1998
Decision Date 10/16/1998
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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