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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Natriuretic Peptide
510(k) Number K031038
Device Name ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
Applicant
Bayer Healthcare, LLC
511 Benedict Ave.
New York,  NY  10591
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Healthcare, LLC
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact KENNETH T EDDS
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJX  
Date Received04/01/2003
Decision Date 06/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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