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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 K090346
Device Name ADVIA 2120/2120I BODY FLUIDS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Applicant Contact Ernest Joseph
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact Ernest Joseph
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/11/2009
Decision Date 07/28/2010
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
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