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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test,Alpha-Fetoprotein For Testicular Cancer
510(k) Number K080017
Device Name VIDAS AFP 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
LOJ  
Date Received01/03/2008
Decision Date 09/26/2008
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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