K240686
- 510(k) number
- K240686
- 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
- 2024-04-12
- Date received
- 2024-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
510(k) Summary (official FDA PDF): K240686.pdf
Official FDA record: K240686
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.