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 K251595
Device Name COVID-19 Detect Rapid Self -Test
Applicant
InBios International, Inc.
307 Westlake Ave. N, Suite 300
Seattle,  WA  98109
Applicant Contact Annabel Tsai
Correspondent
InBios International, Inc.
307 Westlake Ave. N, Suite 300
Seattle,  WA  98109
Correspondent Contact Estela Raychaudhuri
Classification Product Code
QYT  
Date Received05/27/2025
Decision Date 10/12/2025
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
-
-