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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
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