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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, thyroid-stimulating hormone
510(k) Number K160647
Device Name IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591 -5097
Applicant Contact Matthew Gee
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10591 -5097
Correspondent Contact Matthew Gee
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
CEC  
Date Received03/07/2016
Decision Date 05/31/2016
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
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