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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 K081641
Device Name COULTER LIN-X LINEARITY CONTROL
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI,  FL  33196 -2500
Applicant Contact NANCY NADLER
Correspondent
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI,  FL  33196 -2500
Correspondent Contact NANCY NADLER
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/11/2008
Decision Date 01/16/2009
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
Predetermined Change
Control Plan Authorized		 No
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