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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 K813392
Device Name RADIOIMMUNOASSAY FOR HUMAN THYROID
Applicant
Leeco Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Leeco Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1690
Classification Product Code
JLW  
Date Received12/03/1981
Decision Date 12/22/1981
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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