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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), Rabbit Antibody, Polyethylene Glycol
510(k) Number K803045
Device Name IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
Applicant
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3320
Classification Product Code
DOG  
Date Received12/01/1980
Decision Date 12/22/1980
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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