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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, beta-2-microglobulin immunological
510(k) Number K964767
Device Name QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
minneapolis,  MN  55413
Applicant Contact kenneth t edds
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
minneapolis,  MN  55413
Correspondent Contact kenneth t edds
Regulation Number866.5630
Classification Product Code
JZG  
Date Received11/27/1996
Decision Date 05/29/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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