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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioassay, vitamin b12
510(k) Number K041133
Device Name MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact ANDRES HOLLE
Correspondent
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact ANDRES HOLLE
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CDP   CDZ   CEC   CEP   CEW  
CFT   CGJ   CGN   DDR   DGC   DIS  
DKB   JHI   JIT   JJE   JJX   JLS  
JLW   JZO   KHQ   LCD   LCR   LEH  
LFX   LGD   LGR   LGS   LPS  
Date Received04/30/2004
Decision Date 07/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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