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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 K121951
Device Name LIAISON FTA LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
Applicant
DIASORIN, INC.
1951 northwestern ave.
p.o. box 285
stillwater,  MN  55082 0285
Contact kelly r sauer
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JJX  
Date Received07/03/2012
Decision Date 04/04/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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