510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name system, test, immunological, antigen, tumor 510(k) Number K033036 Device Name BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 Applicant BECKMAN COULTER, INC. 1000 lake hazeltine dr. chaska,  MN  55318 108 Contact brent taber Regulation Number 866.6010 Classification Product Code MOI   Subsequent Product Code JIT   Date Received 09/29/2003 Decision Date 02/03/2004 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Immunology Review Advisory Committee Immunology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No