Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-