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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 K983715
Device Name THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number866.6010
Classification Product Code
LTK  
Date Received10/21/1998
Decision Date 05/14/1999
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
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