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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 K123379
Device Name ABBOTT ARCHITECT FREE T4
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact JACEK GORZOWSKI
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact JACEK GORZOWSKI
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Codes
JIT   JJX  
Date Received11/01/2012
Decision Date 11/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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