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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K082503
Device Name DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
Applicant
Siemens Healthcare Diagnostics
500 Gbc
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ANNA MARIE KATHLEEN ENNIS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ANNA MARIE KATHLEEN ENNIS
Regulation Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received08/29/2008
Decision Date 12/19/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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