DeviceClearance

Product code LJX— Hematology

DIASCREEN REAGENT STRIPS

Classification name
Test, Urine Leukocyte
Device class
Class 1
Regulation
21 CFR 864.7675
Advisory panel
Hematology
Total cleared
7
First cleared
Most recent

Market context for product code LJX

FDA has cleared 7 devices under product code LJX between 1985 and 2023, filed by 6 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 LJX

Recent clearances under product code LJX

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