Healgen Scientific

Timeline

1. Apr 13, 2026 FDA FDA 510(k) clearance: Heal-Check Rapid COVID-19 Antigen Self-Test — K260095, Apr 13, 2026. Applicant at approval: Healgen Scientific,, LLC. source ↗
2. Mar 16, 2026 FDA FDA 510(k) clearance: Healgen® Accurate Oral Fluid Drug Test — K253705, Mar 16, 2026. Applicant at approval: Healgen Scientific,, LLC. source ↗
3. Feb 12, 2026 FDA FDA 510(k) clearance: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test — K252523, Feb 12, 2026. Applicant at approval: Healgen Scientific,, LLC. source ↗
4. Dec 23, 2025 FDA FDA 510(k) clearance: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card — K253567, Dec 23, 2025. Applicant at approval: Healgen Scientific,, LLC. source ↗
5. Dec 23, 2025 FDA FDA 510(k) clearance: Healgen® URS Test Strips — K251800, Dec 23, 2025. Applicant at approval: Healgen Scientific,, LLC. source ↗
6. Aug 15, 2025 FDA FDA 510(k) clearance: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) — K251972, Aug 15, 2025. Applicant at approval: Hea source ↗
7. Dec 17, 2024 FDA FDA 510(k) clearance: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup — K243365, Dec 17, 2024. Applicant at approval: Healgen Scientific,, LLC. source ↗

FDA records (last 2 years)

• Apr 13, 2026 FDA 510(k) clearance: Heal-Check Rapid COVID-19 Antigen Self-Test — K260095, Apr 13, 2026. Applicant at approval: Healgen Scientific,, LLC. source ↗
• Mar 16, 2026 FDA 510(k) clearance: Healgen® Accurate Oral Fluid Drug Test — K253705, Mar 16, 2026. Applicant at approval: Healgen Scientific,, LLC. source ↗
• Feb 12, 2026 FDA 510(k) clearance: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test — K252523, Feb 12, 2026. Applicant at approval: Healgen Scientific,, LLC. source ↗
• Dec 23, 2025 FDA 510(k) clearance: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card — K253567, Dec 23, 2025. Applicant at approval: Healgen Scientific,, LLC. source ↗
• Dec 23, 2025 FDA 510(k) clearance: Healgen® URS Test Strips — K251800, Dec 23, 2025. Applicant at approval: Healgen Scientific,, LLC. source ↗
• Aug 15, 2025 FDA 510(k) clearance: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) — K251972, Aug 15, 2025. Applicant at approval: Healgen Scientific,, LLC. source ↗
• Dec 17, 2024 FDA 510(k) clearance: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup — K243365, Dec 17, 2024. Applicant at approval: Healgen Scientific,, LLC. source ↗