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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 K014270
Device Name MININEPH HUMAN B2-MICROGLOBULIN KIT
Applicant
THE BINDING SITE, LTD.
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
THE BINDING SITE, LTD.
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5630
Classification Product Code
JZG  
Subsequent Product Code
JZW  
Date Received12/27/2001
Decision Date 08/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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