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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 K162977
Device Name ADVIA 2120i, ADVIA 2120
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 BENEDICT AVENUE
TARRYTOWN,  NY  10591
Applicant Contact Gerard Sadrakula
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 BENEDICT AVENUE
TARRYTOWN,  NY  10591
Correspondent Contact Gerard Sadrakula
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/26/2016
Decision Date 08/11/2017
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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