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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 K904822
Device Name ELEGANCE FERRITIN ELISA
Applicant
Bioclone Australia Pty , Ltd.
C/O Mackler & Gibbs, P.C.
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Applicant Contact BRUCE MACKLER
Correspondent
Bioclone Australia Pty , Ltd.
C/O Mackler & Gibbs, P.C.
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Correspondent Contact BRUCE MACKLER
Regulation Number866.5340
Classification Product Code
DBF  
Date Received10/24/1990
Decision Date 11/29/1990
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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