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.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- 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.