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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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