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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 K040425
Device Name ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
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 Number862.1117
Classification Product Code
NBC  
Date Received02/18/2004
Decision Date 06/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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