K251091
- 510(k) number
- K251091
- Device name
- Lipids
- Applicant
- Truvian Health CA · US
- Product code
- CHH — Enzymatic Esterase--Oxidase, Cholesterol
- Decision date
- 2025-12-30
- Date received
- 2025-04-10
- 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: K251091.pdf
Official FDA record: K251091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.