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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 K080469
Device Name VIDAS CA 15-3 ASSAY
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact NIKITA S MAPP
Correspondent
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact NIKITA S MAPP
Regulation Number866.6010
Classification Product Code
LTK  
Date Received02/21/2008
Decision Date 06/22/2009
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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