Data / Medical devices / United States / Healgen Life Science LLC
Healgen Life Science LLC: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance
Healgen Life Science LLC is registered with the FDA (registration 3038371335) in Houston, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038371335
- Address
- 3818 Fuqua St, Houston, TX, United States, 77047
- Owner or operator
- Healgen Life Science LLC (10093264)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 19, 2025
- Registered through
- 2027
- Brand names listed
- Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative, Healgen Immunofluorescence Analyzer OG-H180
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Fecal Occult Blood | OSL | 2 | Complaint file establishment | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2025 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Fluorometer, For Clinical Use
- All makers of Enzyme Immunoassay, Opiates
- All makers of Control, Fecal Occult Blood
Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.