DeviceClearance

Heal-Check Rapid COVID-19 Antigen Self-Test— 510(k) K260095

Substantially Equivalent

Healgen 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.

Clearance details

Applicant
Healgen Scientific,, LLC
Product code
Code QYT
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.