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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 K140911
Device Name UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
MIAMI,  FL  33196
Applicant Contact BRENT LEMBERG
Correspondent
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
MIAMI,  FL  33196
Correspondent Contact BRENT LEMBERG
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/09/2014
Decision Date 09/05/2014
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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