K243365
- 510(k) number
- K243365
- Device name
- Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-12-17
- Date received
- 2024-10-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K243365.pdf
Official FDA record: K243365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.