FDA 510(k) Applications Submitted by Kristin Maddaloni

FDA 510(k) Number Submission Date Device Name Applicant
K200997 04/16/2020 Lumipulse G CA19-9-N Fujirebio Diagnostics, Inc.
K191973 07/24/2019 Lumpipulse G CA19-9-N Fujirebio Dianostics, Inc.
K192524 09/13/2019 Lumipulse G CA15-3 Fujirebio Diagnostics, Inc.


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