K240949
- 510(k) number
- K240949
- Device name
- Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-05-13
- Date received
- 2024-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240949.pdf
Official FDA record: K240949
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.