K252607
- 510(k) number
- K252607
- Device name
- AllTest Urinary Tract Infection Test
- Applicant
- Hangzhou AllTest Biotech Co., Ltd. CN
- Product code
- JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Decision date
- 2025-10-30
- Date received
- 2025-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252607.pdf
Official FDA record: K252607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.