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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rt-qpcr assay for mrna transcript immune biomarkers
510(k) Number K163260
Device Name SeptiCyte LAB
Applicant
IMMUNEXPRESS, INC.
425 PONTIUS AVE. NORTH
SEATTLE,  WA  98109
Applicant Contact VICTORIA ROTHWELL
Correspondent
IMMUNEXPRESS, INC.
425 PONTIUS AVE. NORTH
SEATTLE,  WA  98109
Correspondent Contact VICTORIA ROTHWELL
Regulation Number866.3215
Classification Product Code
PRE  
Date Received11/21/2016
Decision Date 02/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01905033
NCT02127502
Reviewed by Third Party No
Combination Product No
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