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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K791361
Device Name T3 UPTAKE RADIOIMMUNOASSAY KIT
Applicant
Technia Diagnostics , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Technia Diagnostics , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received07/20/1979
Decision Date 08/16/1979
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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