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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Automated Blood Cell Diluting
510(k) Number K021150
Device Name COULTER CELLPREP
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI,  FL  33196 -2500
Applicant Contact LOURDES COBA
Correspondent
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI,  FL  33196 -2500
Correspondent Contact LOURDES COBA
Regulation Number864.5240
Classification Product Code
GKH  
Date Received04/10/2002
Decision Date 06/11/2002
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
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