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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Covid-19 Antigen Test
510(k) Number K260754
Device Name Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
Applicant
Assure Tech., LLC
1521 Concord Pike, Suite 201
Wilmington,  DE  19803
Applicant Contact Allen Chen
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Classification Product Code
QYT  
Date Received03/09/2026
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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