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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K991907
Device Name ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA, JR
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA, JR
Regulation Number866.5240
Classification Product Code
CZW  
Subsequent Product Codes
CFQ   DBI   DDG   KTO   LEG  
LEH  
Date Received06/07/1999
Decision Date 11/09/1999
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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