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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 K771590
Device Name THYROID STIMULATING HORMONE
Applicant
New England Nuclear
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
New England Nuclear
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1690
Classification Product Code
JLW  
Date Received08/19/1977
Decision Date 09/15/1977
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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