# Healgen Scientific,, LLC

- Location (FDA's records): Bellaire, TX
- FDA decisions: 27 (2012–2026): 27 510(k) clearances
- Product codes: NGL (4), JXM (4), DJG (3), LDJ (2), GTY (1), LFG (1), LJX (1), DJC (1), NFW (1), JIO (1), DIO (1), DIS (1)
- 510(k) review time since 2016: median 50 days, against 40 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 48 (29 its own); citations of its devices by later devices: 32 (29 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- First Check Diagnostics, LLC: 5 (https://510kreport.com/company/first-check-diagnostics)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Co-Innovation Biotech Co., Ltd.: 1 (https://510kreport.com/company/co-innovation-biotech)
- Teco Diagnostics: 1 (https://510kreport.com/company/teco-diagnostics)
- Premier Biotech, Inc.: 1 (https://510kreport.com/company/premier-biotech)
- Dirui Industrial Co., Ltd.: 1 (https://510kreport.com/company/dirui-industrial)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Guangzhou Decheng Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-decheng-biotechnology)

## Firms that cite its devices most
- Anhui Deepblue Medical Technological Co., Ltd.: 1 (https://510kreport.com/company/anhui-deepblue-medical-technological)
- Safecare Biotech (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/safecare-biotech-hangzhou)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)

## Its most-cited devices
- K142280: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (2014), cited by 4
- K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card) (2014), cited by 4
- K140546: Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test (2014), cited by 4
- K143187: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (2015), cited by 4
- K231045: Healgen URS Test Strips (2023), cited by 3
- K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (2024), cited by 3

## Recent decisions
- K260095: Heal-Check Rapid COVID-19 Antigen Self-Test (Apr 13, 2026)
- K253705: Healgen® Accurate Oral Fluid Drug Test (Mar 16, 2026)
- K252523: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (Feb 12, 2026)
- K253567: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (Dec 23, 2025)
- K251800: Healgen® URS Test Strips (Dec 23, 2025)
- K251972: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (Aug 15, 2025)
- K243365: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (Dec 17, 2024)
- 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) (May 13, 2024)

Source page: https://510kreport.com/company/healgen-scientific