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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 K032013
Device Name COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
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 Number864.5220
Classification Product Code
GKZ  
Date Received06/30/2003
Decision Date 07/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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