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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
510(k) Number K031393
Device Name BAYER ADVIA CENTAUR CA 19-9 ASSAY
Applicant
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact KENNETH T EDDS
Regulation Number866.6010
Classification Product Code
NIG  
Subsequent Product Code
JIT  
Date Received05/02/2003
Decision Date 06/24/2003
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
Recalls CDRH Recalls
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