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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 K043228
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 CAROL BIANCA
Correspondent
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact CAROL BIANCA
Regulation Number862.1117
Classification Product Code
NBC  
Date Received11/22/2004
Decision Date 04/22/2005
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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