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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
Recalls CDRH Recalls
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