DeviceClearance

Product code CDT— Clinical Chemistry

TRIGLYCERIDE REAGENT SET

Classification name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device class
Class 1
Regulation
21 CFR 862.1705
Advisory panel
Clinical Chemistry
Total cleared
151
First cleared
Most recent

Market context for product code CDT

FDA has cleared 151 devices under product code CDT between 1976 and 2015, filed by 87 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 CDT

Recent clearances under product code CDT

1–100 of 151

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