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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name method, nephelometric, immunoglobulins (g, a, m)
510(k) Number K130122
Device Name BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
Applicant
BECKMAN COULTER, INC
250 S. KRAEMER BLVD
E1.SE. 01
BREA,  CA  92821
Applicant Contact AMANDA BROWN
Correspondent
BECKMAN COULTER, INC
250 S. KRAEMER BLVD
E1.SE. 01
BREA,  CA  92821
Correspondent Contact AMANDA BROWN
Regulation Number866.5510
Classification Product Code
CFN  
Subsequent Product Code
JIX  
Date Received01/17/2013
Decision Date 01/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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