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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 K043215
Device Name FLOWCARE PLG CD4 REAGENT
Applicant
BECKMAN COULTER, INC.
11800 S.W. 147 AVE.
MIAMI,  FL  33196 -2500
Applicant Contact STAN SUGRUE
Correspondent
BECKMAN COULTER, INC.
11800 S.W. 147 AVE.
MIAMI,  FL  33196 -2500
Correspondent Contact STAN SUGRUE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/19/2004
Decision Date 01/19/2005
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
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