CHH

Enzymatic Esterase--Oxidase, Cholesterol

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)

Last three years. Most recent: 2025-12-30.

NumberDecision dateApplicantDevice nameSummary
K2510912025-12-30Truvian HealthLipidsPDF
K2324042024-08-09Medicon Hellas S.ACHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIG…PDF

2 summaries are archived here for direct download.

Official FDA classification page: CHH
Classification and pathway per current FDA publications. Data from openFDA (CC0).