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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, Immunological, Antigen, Tumor
510(k) Number K192524
Device Name Lumipulse G CA15-3
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Applicant Contact Kristin Maddaloni
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Correspondent Contact Kristin Maddaloni
Regulation Number866.6010
Classification Product Code
MOI  
Date Received09/13/2019
Decision Date 09/04/2020
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
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