K251800
- 510(k) number
- K251800
- Device name
- Healgen® URS Test Strips
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Decision date
- 2025-12-23
- Date received
- 2025-06-12
- 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: K251800.pdf
Official FDA record: K251800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.