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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 K051215
Device Name CELL-DYN SAPPHIRE SYSTEM
Applicant
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Applicant Contact MICHELLE ROEDING
Correspondent
ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA,  CA  95054
Correspondent Contact MICHELLE ROEDING
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/12/2005
Decision Date 07/21/2005
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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