Medical Device Manufacturer · US , Houston , TX

Healgen Scientific, LLC

25 submissions · 25 cleared · Since 2012
25
Total
25
Cleared
0
Denied

Healgen Scientific, LLC — FDA 510(k) Submissions

Healgen Scientific, LLC has submitted 25 FDA 510(k) premarket notifications since 2012, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Benzodiazepine, Test, Opiates, Over The Counter, Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Cannabinoids, Test, Cannabinoid, Over The Counter . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
Healgen? Accurate Oral Fluid Drug Test COT/THC; Healgen? Accurate Oral Fluid Drug Test
K252523 · NFW Test, Cannabinoid, Over... · Toxicology
Feb 2026 185d
Healgen? URS Test Strips
K251800 · JMT Diazo (colorimetric),... · Chemistry
Dec 2025 194d
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
K253567 · NGL Test, Opiates, Over The... · Toxicology
Dec 2025 36d
Healgen? AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen? Immunofluorescence Analyzer (OG-H180)
K251972 · DJG Enzyme Immunoassay, Opiates · Toxicology
Aug 2025 50d
Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
K243365 · NGL Test, Opiates, Over The... · Toxicology
Dec 2024 49d
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)
K240949 · NGL Test, Opiates, Over The... · Toxicology
May 2024 35d
Healgen Rapid COVID-19 Antigen Test
K232377 · QVF Simple Point-of-care... · Microbiology
Apr 2024 255d
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
K240686 · NGL Test, Opiates, Over The... · Toxicology
Apr 2024 31d
Healgen URS Test Strips
K231045 · LJX Test, Urine Leukocyte · Chemistry
Jun 2023 65d
Healgen? Accurate Oral Fluid Drug Test, Healgen? Accurate Oral Fluid Drug Test COT
K223162 · LDJ Enzyme Immunoassay,... · Toxicology
Mar 2023 161d
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · GTY Antigens, All Groups,... · Microbiology
Mar 2022 210d
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
K163704 · JXM Enzyme Immunoassay,... · Toxicology
Aug 2017 216d
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · JXM Enzyme Immunoassay,... · Toxicology
May 2016 159d
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
K152269 · DKZ Enzyme Immunoassay,... · Toxicology
Sep 2015 29d
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
K151348 · LFG Radioimmunoassay,... · Toxicology
Aug 2015 90d
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K151642 · JXM Enzyme Immunoassay,... · Chemistry
Aug 2015 56d
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K150356 · JXM Enzyme Immunoassay,... · Chemistry
May 2015 90d
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
K150791 · DIS Enzyme Immunoassay,... · Toxicology
Apr 2015 30d
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
K150096 · LAF Gas Chromatography,... · Toxicology
Mar 2015 43d
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
K143187 · DJG Enzyme Immunoassay, Opiates · Chemistry
Jan 2015 83d
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
K142280 · DJG Enzyme Immunoassay, Opiates · Chemistry
Oct 2014 62d
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
K141647 · DIO Enzyme Immunoassay,... · Chemistry
Jul 2014 28d
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
K140546 · LDJ Enzyme Immunoassay,... · Chemistry
Jun 2014 94d
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
K123703 · LCX Kit, Test, Pregnancy,... · Chemistry
Apr 2013 128d
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
K111999 · JIO Blood, Occult,... · Chemistry
Apr 2012 279d
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