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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 SW 147 Ave.
Miami,  FL  33196
Applicant Contact STAN SUGRUE
Correspondent
Beckman Coulter, Inc.
11800 SW 147 Ave.
Miami,  FL  33196
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
Predetermined Change
Control Plan Authorized		 No
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