DeviceClearance

Product code CDZ— Clinical Chemistry

DELFIA SHBG KIT

Classification name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device class
Class 1
Regulation
21 CFR 862.1680
Advisory panel
Clinical Chemistry
Total cleared
89
First cleared
Most recent

Market context for product code CDZ

FDA has cleared 89 devices under product code CDZ between 1978 and 2026, filed by 48 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 CDZ

Recent clearances under product code CDZ

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