Heal-Check Rapid COVID-19 Antigen Self-Test— 510(k) K260095
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K260095 for Heal-Check Rapid COVID-19 Antigen Self-Test, Substantially Equivalent on 2026-04-13. Applicant: Healgen Scientific,, LLC. Device class: 2.
Summary
Healgen Scientific's Heal-Check Rapid COVID-19 Antigen Self-Test is filed under product code QYT (Over-The-Counter Covid-19 Antigen Test).
Class II, 21 CFR 866.3984. It came in as a Traditional 510(k), and Microbiology is both the classification panel and the review panel.
Healgen Scientific filed from Houston, Texas. Review took 90 calendar days (January 13 to April 13, 2026).
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Product code QYT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.