K240295
- 510(k) number
- K240295
- Device name
- InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)
- Applicant
- Instanosis, Inc. PA · US
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-03-28
- Date received
- 2024-02-01
- 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: K240295.pdf
Official FDA record: K240295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.