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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 K972162
Device Name ELECSYS CA 125 II
Applicant
Boehringer Mannheim Corp.
9112 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact LEEANN CHAMBERS
Correspondent
Boehringer Mannheim Corp.
9112 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact LEEANN CHAMBERS
Regulation Number866.6010
Classification Product Code
LTK  
Date Received06/09/1997
Decision Date 03/18/1998
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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