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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 K232095
Device Name SeptiCyte RAPID
Applicant
Immunexpress, Inc.
425 Pontius Ave. N.
Suite 470
Seattle,  WA  98109
Applicant Contact LaKesha Hunt-Dickens
Correspondent
Immunexpress, Inc.
425 Pontius Ave. N.
Suite 470
Seattle,  WA  98109
Correspondent Contact LaKesha Hunt-Dickens
Regulation Number866.3215
Classification Product Code
PRE  
Date Received07/13/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01905033
NCT02127502
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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