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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 K203748
Device Name SeptiCyte RAPID
Applicant
Immunexpress, Inc
425 Pontius Avenue North, Suite 470
Seattle,  WA  98109
Applicant Contact LaKesha Hunt-Dickens
Correspondent
Immunexpress, Inc
425 Pontius Avenue North, Suite 470
Seattle,  WA  98109
Correspondent Contact LaKesha Hunt-Dickens
Regulation Number866.3215
Classification Product Code
PRE  
Date Received12/23/2020
Decision Date 11/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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