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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 K812666
Device Name THYROXINE (T4) 125I
Applicant
Pcl-Ria, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pcl-Ria, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1710
Classification Product Code
CDP  
Date Received09/21/1981
Decision Date 10/02/1981
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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