K232404
- 510(k) number
- K232404
- Device name
- CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
- Applicant
- Medicon Hellas S.A GR
- Product code
- CHH — Enzymatic Esterase--Oxidase, Cholesterol
- Decision date
- 2024-08-09
- Date received
- 2023-08-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232404.pdf
Official FDA record: K232404
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.