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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K082638
Device Name ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Newark,  DE  19714
Applicant Contact YUK-TING LEWIS
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact YUK-TING LEWIS
Regulation Number862.1700
Classification Product Code
KLI  
Subsequent Product Code
JJE  
Date Received09/10/2008
Decision Date 02/26/2009
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
Recalls CDRH Recalls
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