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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 K120771
Device Name UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
MIAMI,  FL  33196 -2500
Applicant Contact ERIC GRACE
Correspondent
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
MIAMI,  FL  33196 -2500
Correspondent Contact ERIC GRACE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/14/2012
Decision Date 03/22/2013
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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