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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Erythropoietin
510(k) Number K052223
Device Name ACCESS EPO ASSAY
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact LYNN WEIST
Correspondent
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact LYNN WEIST
Regulation Number864.7250
Classification Product Code
GGT  
Subsequent Product Code
JIT  
Date Received08/15/2005
Decision Date 10/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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