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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 K960427
Device Name ABBOTT CELL-DYN 3500R SYSTEM
Applicant
SEQUOIA TURNER CORP.
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Applicant Contact JANICE E BROWN
Correspondent
SEQUOIA TURNER CORP.
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Correspondent Contact JANICE E BROWN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/29/1996
Decision Date 05/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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