DeviceClearance

Product code JHO— Clinical Chemistry

CHOLESTEROL REAGENT SUBSTRATE SET

Classification name
Electrophoretic Separation, Lipoproteins
Device class
Class 1
Regulation
21 CFR 862.1475
Advisory panel
Clinical Chemistry
Total cleared
26
First cleared
Most recent

Market context for product code JHO

FDA has cleared 26 devices under product code JHO between 1978 and 2002, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code JHO

Recent clearances under product code JHO

Data sourced from openFDA. This site is unofficial and independent of the FDA.