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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K000662
Device Name RANDOX FERRITIN
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin, Co. Antrim,  IE BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin, Co. Antrim,  IE BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number866.5340
Classification Product Code
DBF  
Date Received02/28/2000
Decision Date 04/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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