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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 K051122
Device Name ITAG MHC TETRAMER CMV ASSAY
Applicant
BECKMAN COULTER, INC.
7330 CARROLL RD.
SAN DIEGO,  CA  92121
Applicant Contact MARA CALER
Correspondent
BECKMAN COULTER, INC.
7330 CARROLL RD.
SAN DIEGO,  CA  92121
Correspondent Contact MARA CALER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/02/2005
Decision Date 08/01/2005
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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