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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 Thyroxine
510(k) Number K771609
Device Name PEDIATRIC THYROXINE TEST SYS. T4
Applicant
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1700
Classification Product Code
CDX  
Date Received08/22/1977
Decision Date 12/20/1977
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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