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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K061137
Device Name ADVIA IMS CPSA CONTROL
Applicant
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact ANDRES HOLLE
Correspondent
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact ANDRES HOLLE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/24/2006
Decision Date 07/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
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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