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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 K010953
Device Name CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
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 Received03/30/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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