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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 K791375
Device Name AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
Applicant
Micromedic Systems
MD 
Correspondent
Micromedic Systems
MD 
Regulation Number862.1710
Classification Product Code
CDP  
Date Received07/24/1979
Decision Date 10/11/1979
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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