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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K781150
Device Name RIA TSH IN HUMAN SERUM OR PLASMA
Applicant
Diagnostic Corp. of America
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diagnostic Corp. of America
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1690
Classification Product Code
JLW  
Date Received07/10/1978
Decision Date 07/27/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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