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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K791128
Device Name PTH RIA 200
Applicant
Institut National Des Radioelements
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Institut National Des Radioelements
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1545
Classification Product Code
CEW  
Date Received06/18/1979
Decision Date 09/27/1979
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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