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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 K972354
Device Name ABBOTT CELL-DYN 3200 SYSTEM
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact SUE E LUPTOVIC
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact SUE E LUPTOVIC
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/24/1997
Decision Date 09/16/1997
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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