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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 K020807
Device Name AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact KENNETH T EDDS
Correspondent
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact KENNETH T EDDS
Regulation Number866.6010
Classification Product Code
LOJ  
Date Received03/12/2002
Decision Date 10/01/2002
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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