DeviceClearance

Product code JZX— Immunology

ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS

Classification name
Equipment, Rocket Immunoelectrophoresis
Device class
Class 1
Regulation
21 CFR 866.4830
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

Market context for product code JZX

FDA has cleared 1 device under product code JZX, all in 1994, filed by 1 applicant company. 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.

Top applicants under product code JZX

Recent clearances under product code JZX

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