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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 K800374
Device Name AMERLEX T-3 RIA KIT
Applicant
AMERSHAM CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERSHAM CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1710
Classification Product Code
CDP  
Date Received02/21/1980
Decision Date 03/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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