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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name immunochemical, transferrin
510(k) Number K970718
Device Name QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Applicant Contact KENNETH T EDDS, PH.D.
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Correspondent Contact KENNETH T EDDS, PH.D.
Regulation Number866.5880
Classification Product Code
JNM  
Date Received02/26/1997
Decision Date 05/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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