K252523
- 510(k) number
- K252523
- Device name
- Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- NFW — Test, Cannabinoid, Over The Counter
- Decision date
- 2026-02-12
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252523.pdf
Official FDA record: K252523
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.