K243996
- 510(k) number
- K243996
- Device name
- AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
- Applicant
- Assure Tech., LLC DE · US
- Product code
- NFT — Test, Amphetamine, Over The Counter
- Decision date
- 2025-02-07
- Date received
- 2024-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243996.pdf
Official FDA record: K243996
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.