K250803
- 510(k) number
- K250803
- Device name
- Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
- Applicant
- Anhui Deepblue Medical Technological Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2025-04-15
- Date received
- 2025-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250803.pdf
Official FDA record: K250803
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.