K253567
- 510(k) number
- K253567
- Device name
- Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2025-12-23
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253567.pdf
Official FDA record: K253567
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.