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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K031857
Device Name ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
Applicant
Bayer Diagnostics Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact ANDRES HOLLE
Correspondent
Bayer Diagnostics Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact ANDRES HOLLE
Regulation Number866.5130
Classification Product Code
DEM  
Date Received06/16/2003
Decision Date 09/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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