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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 K032525
Device Name BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Original Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown,  NY  10591
Original Contact andres holle
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
CDD   CDZ   CEC   CEP   CFT  
CGJ   CGN   CHP   DBF   DDR   DGC  
DHX   DIS   DKB   GWG   JFT   JHI  
JIT   JJE   JJX   JLS   JLW   JZO  
KHQ   KXT   LCD   LCR   LEH   LFM  
LFX   LGD   LGR   LGS   LOQ   LPS  
LTJ   LTK   MMI   MOI   NIG  
Date Received08/15/2003
Decision Date 09/09/2003
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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