CHH
- Product code
- CHH
- Device name
- Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class 1
- 21 CFR
- 21 CFR 862.1175
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 230 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251091 | 2025-12-30 | Truvian Health | Lipids | |
| K232404 | 2024-08-09 | Medicon Hellas S.A | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIG… |
Official FDA classification page: CHH
Classification and pathway per current FDA publications. Data from openFDA (CC0).