Product code LKL— Immunology

AL-ACID GLYCOPROTEIN RID KIT

Classification name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device class
Class 1
Regulation
21 CFR 866.5420
Advisory panel
Immunology
Total cleared
11
First cleared
Most recent

Market context for product code LKL

FDA has cleared 11 devices under product code LKL between 1983 and 1999, filed by 10 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 LKL

Recent clearances under product code LKL

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