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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 K143534
Device Name Elecsys CA-125 II assay
Applicant
Roche Professional Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact LINDA MCCAMMACK
Correspondent
Roche Professional Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact LINDA MCCAMMACK
Regulation Number866.6010
Classification Product Code
LTK  
Subsequent Product Code
JJX  
Date Received12/12/2014
Decision Date 08/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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