Product code LCI— Clinical Chemistry

25-HYDROXYVITAMIN D 125I RIA KIT

Classification name
Automated Radioimmunoassay Systems, For Clinical Use
Device class
Class 1
Regulation
21 CFR 862.2050
Advisory panel
Clinical Chemistry
Total cleared
3
First cleared
Most recent

Market context for product code LCI

FDA has cleared 3 devices under product code LCI between 1978 and 1998, filed by 3 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

Top applicants under product code LCI

Recent clearances under product code LCI

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