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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 K913562
Device Name QMS - DIGOXIN
Applicant
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact MICHAEL SULLIVAN
Correspondent
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact MICHAEL SULLIVAN
Regulation Number862.3320
Classification Product Code
LCS  
Date Received08/09/1991
Decision Date 08/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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