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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 K170065
Device Name ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Applicant Contact Julie Warren
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact Julie Warren
Regulation Number862.1110
Classification Product Code
JFM  
Subsequent Product Code
MQM  
Date Received01/09/2017
Decision Date 03/09/2017
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
Recalls CDRH Recalls
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