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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (125-I)
510(k) Number K801413
Device Name AMERLEX DIGOXIN 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 Number862.3320
Classification Product Code
LCS  
Date Received06/16/1980
Decision Date 07/08/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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