Company · US
Healgen Scientific,, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (5 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | 4 |
| NGL | Test, Opiates, Over The Counter | 4 |
| DJG | Enzyme Immunoassay, Opiates | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 1 |
| LJX | Test, Urine Leukocyte | 1 |
| NFW | Test, Cannabinoid, Over The Counter | 1 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 13, 2026 | K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test Healgen Scientific,, LLC | QYT |
| Mar 16, 2026 | K253705 | Healgen® Accurate Oral Fluid Drug Test Healgen Scientific,, LLC | DJC |
| Feb 12, 2026 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test Healgen Scientific,, LLC | NFW |
| Dec 23, 2025 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card Healgen Scientific,, LLC | NGL |
| Dec 23, 2025 | K251800 | Healgen® URS Test Strips Healgen Scientific,, LLC | JMT |
| Aug 15, 2025 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer ( Healgen Scientific,, LLC | DJG |
| Dec 17, 2024 | K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup Healgen Scientific,, LLC | NGL |
| May 13, 2024 | K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Healgen Scientific,, LLC | NGL |
| Apr 19, 2024 | K232377 | Healgen Rapid COVID-19 Antigen Test Healgen Scientific,, LLC | QVF |
| Apr 12, 2024 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card Healgen Scientific,, LLC | NGL |
| Jun 16, 2023 | K231045 | Healgen URS Test Strips Healgen Scientific,, LLC | LJX |
| Mar 17, 2023 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT Healgen Scientific,, LLC | LDJ |
| Mar 16, 2022 | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) Healgen Scientific,, LLC | GTY |
| Aug 2, 2017 | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card Healgen Scientific,, LLC | JXM |
| May 23, 2016 | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card Healgen Scientific,, LLC | JXM |
| Sep 9, 2015 | K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healge Healgen Scientific,, LLC | DKZ |
| Aug 18, 2015 | K151348 | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC | LFG |
| Aug 13, 2015 | K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card Healgen Scientific,, LLC | JXM |
| May 13, 2015 | K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card Healgen Scientific,, LLC | JXM |
| Apr 24, 2015 | K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC | DIS |
| Mar 4, 2015 | K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card Healgen Scientific,, LLC | LAF |
| Jan 27, 2015 | K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) Healgen Scientific,, LLC | DJG |
| Oct 16, 2014 | K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) Healgen Scientific,, LLC | DJG |
| Jul 17, 2014 | K141647 | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) Healgen Scientific,, LLC | DIO |
| Jun 6, 2014 | K140546 | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST Healgen Scientific,, LLC | LDJ |
| Apr 10, 2013 | K123703 | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) Healgen Scientific,, LLC | LCX |
| Apr 17, 2012 | K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL Healgen Scientific,, LLC | JIO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2024 | Healgen Scientific Llc Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color Open, Classified |
JIR | K111999 |