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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 K885258
Device Name ACA THYROXINE (T4 E) METHOD
Applicant
The DU Pont Co.
Chestnut Run Plz.
P.O. Box 80715
Wilmington,  DE 
Applicant Contact RICHARD M VAUGHT
Correspondent
The DU Pont Co.
Chestnut Run Plz.
P.O. Box 80715
Wilmington,  DE 
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1700
Classification Product Code
KLI  
Date Received12/23/1988
Decision Date 02/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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