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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Free Thyroxine
510(k) Number K080167
Device Name ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
Applicant
Siemens Healthcare Diagnostics
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact PHILIP LIU
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact PHILIP LIU
Regulation Number862.1695
Classification Product Code
CEC  
Date Received01/23/2008
Decision Date 08/08/2008
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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