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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
510(k) Number K020828
Device Name CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact KENNETH T EDDS
Regulation Number866.6010
Classification Product Code
LTK  
Date Received03/14/2002
Decision Date 07/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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