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510(k) K163260

Device
SeptiCyte LAB
Applicant
IMMUNEXPRESS, INC.
510(k) number
K163260
Product code
PRE  
Decision
Substantially Equivalent (SESE)
Decision date
2017-02-17
Date received
2016-11-21
Regulation
866.3215
Classification name
Rt-qpcr Assay For Mrna Transcript Immune Biomarkers
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VICTORIA ROTHWELL
Address
425 Pontius Ave. N Seattle WA US 98109 98109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PRE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241676TriVerityInflammatix, Inc.2025-01-10
K232095SeptiCyte RAPIDImmunexpress, Inc.2023-12-15
K203748SeptiCyte RAPIDImmunexpress, Inc.2021-11-29

Legacy Summary#

summary

FDA Review#

Decision Summary