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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, Coated Tube Sep.
510(k) Number K914833
Device Name IMMULITE DIGOXIN
Applicant
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Applicant Contact M.DI TULLIO
Correspondent
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Correspondent Contact M.DI TULLIO
Regulation Number862.3320
Classification Product Code
DPO  
Date Received10/25/1991
Decision Date 11/22/1991
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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