Healgen Scientific, LLC - FDA 510(k) Cleared Devices
26
Total
26
Cleared
0
Denied
Healgen Scientific, LLC has 26 FDA 510(k) cleared medical devices. Based in Houston, US.
Latest FDA clearance: Mar 2026. Active since 2012. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Healgen Scientific, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Healgen Scientific, LLC
26 devices
Cleared
Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
Toxicology
112d
Cleared
Feb 12, 2026
Healgen® Accurate Oral Fluid Drug Test COT/THC
Toxicology
185d
Cleared
Dec 23, 2025
Healgen® URS Test Strips
Chemistry
194d
Cleared
Dec 23, 2025
Healgen Accurate Urine Drug Screen Dip Card
Toxicology
36d
Cleared
Aug 15, 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
Toxicology
50d
Cleared
Dec 17, 2024
Healgen Accurate Muti-Drug Urine Drug Screen Cup
Toxicology
49d
Cleared
May 13, 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
Toxicology
35d
Cleared
Apr 19, 2024
Healgen Rapid COVID-19 Antigen Test
Microbiology
255d
Cleared
Apr 12, 2024
Healgen Accurate Urine Drug Screen Dip Card
Toxicology
31d
Cleared
Jun 16, 2023
Healgen URS Test Strips
Chemistry
65d
Cleared
Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...
Toxicology
161d
Cleared
Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
Microbiology
210d