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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, differential cell
510(k) Number K980614
Device Name ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
Applicant
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Applicant Contact JANICE E BROWN
Correspondent
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Correspondent Contact JANICE E BROWN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/02/1998
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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