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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, Charcoal Sep.
510(k) Number K853021
Device Name OPTIMATE DIGOXIN TEST
Applicant
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Applicant Contact JOHN H ENGELMANN
Correspondent
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Correspondent Contact JOHN H ENGELMANN
Regulation Number862.3320
Classification Product Code
DPB  
Date Received07/18/1985
Decision Date 08/07/1985
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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