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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
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