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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Bilirubin
510(k) Number K063845
Device Name ADVIA CHEMISTRY TOTAL BILIRUBIN_2
Applicant
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact PHILIP LIU
Correspondent
Bayer Healthcare, LLC
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact PHILIP LIU
Regulation Number862.1110
Classification Product Code
JFM  
Date Received12/27/2006
Decision Date 12/07/2007
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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