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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K982714
Device Name BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number866.5340
Classification Product Code
DBF  
Date Received08/04/1998
Decision Date 10/22/1998
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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