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FDA 510(k) Applications for Medical Device Product Code "PRE"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K203748
Immunexpress, Inc
SeptiCyte RAPID
11/29/2021
K232095
Immunexpress, Inc
SeptiCyte RAPID
12/15/2023
K163260
IMMUNEXPRESS, INC.
SeptiCyte LAB
02/17/2017
K241676
Inflammatix, Inc.
TriVerity
01/10/2025
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