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Healgen Scientific,, LLC

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories11
Latest FDA decision2026-04-13
TypeNumberDevice NameCodeDateActions
510(k) K260095 Heal-Check Rapid COVID-19 Antigen Self-TestQYT2026-04-13 View
510(k) K253705 Healgen® Accurate Oral Fluid Drug TestDJC2026-03-16 View
510(k) K252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestNFW2026-02-12 View
510(k) K253567 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardNGL2025-12-23 View
510(k) K251800 Healgen® URS Test StripsJMT2025-12-23 View
510(k) K251972 Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)DJG2025-08-15 View
510(k) K243365 Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupNGL2024-12-17 View
510(k) K240949 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)NGL2024-05-13 View
510(k) K232377 Healgen Rapid COVID-19 Antigen TestQVF2024-04-19 View
510(k) K240686 Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardNGL2024-04-12 View
510(k) K231045 Healgen URS Test StripsLJX2023-06-16 View
510(k) K223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ2023-03-17 View
510(k) K212623 Healgen Strep A Rapid Test Strip (Throat Swab)GTY2022-03-16 View
510(k) K163704 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM2017-08-02 View
510(k) K153597 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23 View
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