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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 K030513
Device Name CELL-DYN 1800 SYSTEM
Applicant
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Applicant Contact JOHN DEAN
Correspondent
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Correspondent Contact JOHN DEAN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/19/2003
Decision Date 05/12/2003
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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