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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 triiodothyronine
510(k) Number K791317
Device Name IREX REAL TIME PHASED ARRAY SYSTEM
Applicant
IREX CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IREX CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1710
Classification Product Code
CDP  
Date Received07/12/1979
Decision Date 09/17/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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