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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 K042251
Device Name BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact ANDRES HOLLE
Correspondent
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact ANDRES HOLLE
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
KPA  
Date Received08/20/2004
Decision Date 09/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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