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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 K842949
Device Name AMERLEX-M FREE T-3 RIA
Applicant
AMERSHAM CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERSHAM CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1710
Classification Product Code
CDP  
Date Received07/06/1984
Decision Date 09/05/1984
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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