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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 K840050
Device Name SOPHEIA T3 EIA KIT
Applicant
DIAGNOSTIC PRODUCTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DIAGNOSTIC PRODUCTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1710
Classification Product Code
CDP  
Date Received01/06/1984
Decision Date 03/19/1984
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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