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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyclosporine
510(k) Number K071455
Device Name ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Applicant Contact MARY SEEGER
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict Avenue
Tarrytown,  NY  10591
Correspondent Contact MARY SEEGER
Regulation Number862.1235
Classification Product Code
MKW  
Subsequent Product Code
DLJ  
Date Received05/25/2007
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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