Healgen Scientific, LLC - FDA 510(k) Cleared Devices

Cleared Mar 16, 2026

Healgen® Accurate Oral Fluid Drug Test

K253705 · DJC

Toxicology · 112d

Cleared Feb 12, 2026

Healgen® Accurate Oral Fluid Drug Test COT/THC

K252523 · NFW

Toxicology · 185d

Cleared Dec 23, 2025

Healgen Accurate Urine Drug Screen Dip Card

K253567 · NGL

Toxicology · 36d

Cleared Aug 15, 2025

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative

K251972 · DJG

Toxicology · 50d

Cleared Dec 17, 2024

Healgen Accurate Muti-Drug Urine Drug Screen Cup

K243365 · NGL

Toxicology · 49d

Cleared May 13, 2024

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)

K240949 · NGL

Toxicology · 35d

Cleared Apr 12, 2024

Healgen Accurate Urine Drug Screen Dip Card

K240686 · NGL

Toxicology · 31d

Cleared Mar 17, 2023

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...

K223162 · LDJ

Toxicology · 161d

Cleared Aug 02, 2017

Healgen Multi-Drug Urine Test Cup

K163704 · JXM

Toxicology · 216d

Cleared May 23, 2016

Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

K153597 · JXM

Toxicology · 159d

Cleared Sep 09, 2015

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine...

K152269 · DKZ

Toxicology · 29d

Cleared Aug 18, 2015

Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen...

K151348 · LFG

Toxicology · 90d