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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K963833
Device Name IMX FREE TRIIODOTHYRONINE (FREE T3)
Applicant
Abbott Laboratories
Dept. 389, Ap30
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Applicant Contact LAURA L GRANITZ
Correspondent
Abbott Laboratories
Dept. 389, Ap30
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Correspondent Contact LAURA L GRANITZ
Regulation Number862.1710
Classification Product Code
CDP  
Subsequent Product Codes
JIS   JJX  
Date Received09/24/1996
Decision Date 10/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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