← Every applicant
Healgen Scientific,, LLC FDA Approvals
0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Heal-Check Rapid COVID-19 Antigen Self-Test510(k)Apr 13, 2026Microbiology |
| Healgen® Accurate Oral Fluid Drug Test510(k)Mar 16, 2026Clinical Toxicology |
| Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test510(k)Feb 12, 2026Clinical Toxicology |
| Healgen® URS Test Strips510(k)Dec 23, 2025Clinical Chemistry |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card510(k)Dec 23, 2025Clinical Toxicology |
| Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)510(k)Aug 15, 2025Clinical Toxicology |
| Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup510(k)Dec 17, 2024Clinical Toxicology |
| Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)510(k)May 13, 2024Clinical Toxicology |
| Healgen Rapid COVID-19 Antigen Test510(k)Apr 19, 2024Microbiology |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card510(k)Apr 12, 2024Clinical Toxicology |
| Healgen URS Test Strips510(k)Jun 16, 2023Hematology |
| Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT510(k)Mar 17, 2023Clinical Toxicology |
| Healgen Strep A Rapid Test Strip (Throat Swab)510(k)Mar 16, 2022Microbiology |