510(k) Archives

Announcements

Healgen® Expands Infectious Disease Portfolio with the Heal-Check Rapid COVID-19 Antigen Self-Test

When COVID-19 symptoms appear, people want answers quickly. A sore throat, fever, cough, fatigue, or exposure concern can create immediate uncertainty, especially when decisions about

April 28, 2026

Announcements

World Health Day 2026: Together for Health – How Healgen Scientific’s Rapid Toxicology Testing Stands with Science to Protect Communities

World Health Day, celebrated every April 7, marks the founding of the World Health Organization (WHO) and rallies global efforts toward better health outcomes. In

April 7, 2026

Announcements

Healgen® Accurate® Oral Fluid Drug Test: A new 510(k) Clearance – Expanding Healgen’s Comprehensive Toxicology Line

Healgen Scientific is proud to announce the FDA 510(k) clearance of the Healgen® Accurate® Oral Fluid Drug Test, a multi-analyte oral fluid screening device that strengthens

March 26, 2026

Announcements

Healgen® Expands Infectious Disease Portfolio with the Heal-Check Rapid COVID-19 Antigen Self-Test

World Health Day 2026: Together for Health – How Healgen Scientific’s Rapid Toxicology Testing Stands with Science to Protect Communities

Healgen® Accurate® Oral Fluid Drug Test: A new 510(k) Clearance – Expanding Healgen’s Comprehensive Toxicology Line

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