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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K983440
Device Name ABBOTT ARCHITECT TOTAL T4
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Applicant Contact APRIL VEOUKAS
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Correspondent Contact APRIL VEOUKAS
Regulation Number862.1700
Classification Product Code
KLI  
Subsequent Product Codes
JIT   JJX  
Date Received09/29/1998
Decision Date 11/25/1998
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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