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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Digoxin
510(k) Number K102346
Device Name RANDOX DIGOXIN ASSAY
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.3320
Classification Product Code
KXT  
Date Received08/19/2010
Decision Date 10/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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