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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 K181475
Device Name DxH 520 Hematology Instrument
Applicant
Beckman Coulter
11800 SW 147th Ave.
Miami,  FL  33196 -2500
Applicant Contact Samy Puccio
Correspondent
Beckman Coulter
11800 SW 147th Ave.
Miami,  FL  33196 -2500
Correspondent Contact Samy Puccio
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/04/2018
Decision Date 03/01/2019
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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