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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mixture, hematology quality control
510(k) Number K082162
Device Name COULTER BODY FLUID CONTROL
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 Number864.8625
Classification Product Code
JPK  
Date Received07/31/2008
Decision Date 02/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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