Product code LIJ— Pathology

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT

Classification name
Peroxidase Anti-Peroxidase Immunohistochemical Stain
Device class
Class 1
Regulation
21 CFR 864.4400
Advisory panel
Pathology
Total cleared
2
First cleared
Most recent

Market context for product code LIJ

FDA has cleared 2 devices under product code LIJ between 1982 and 1986, filed by 2 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 LIJ

Recent clearances under product code LIJ

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