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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Free Thyroxine
510(k) Number K810231
Device Name CODE IM 2050 AMERLEX FREE T4 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 Number862.1695
Classification Product Code
CEC  
Date Received01/27/1981
Decision Date 02/10/1981
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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