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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
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