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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K061139
Device Name BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
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 Number862.1150
Classification Product Code
JIT  
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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