DeviceClearance

Product code GKJ— Hematology

MICRO-MAT SYSTEM

Classification name
Spinner, Slide, Automated
Device class
Class 1
Regulation
21 CFR 864.5850
Advisory panel
Hematology
Total cleared
6
First cleared
Most recent

Market context for product code GKJ

FDA has cleared 6 devices under product code GKJ between 1976 and 1985, filed by 5 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 GKJ

Recent clearances under product code GKJ

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