K251058
- 510(k) number
- K251058
- Device name
- Tru Kidney Health Test Panel; Tru Analyzer
- Applicant
- Truvian Health CA · US
- Product code
- CGX — Alkaline Picrate, Colorimetry, Creatinine
- Decision date
- 2025-11-26
- Date received
- 2025-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251058.pdf
Official FDA record: K251058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.