Product code KJF— Hematology

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY

Classification name
System, Suspension, Cell Culture
Device class
Class 1
Regulation
21 CFR 864.2240
Advisory panel
Hematology
Total cleared
4
First cleared
Most recent

Market context for product code KJF

FDA has cleared 4 devices under product code KJF between 1978 and 1989, filed by 4 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 KJF

Recent clearances under product code KJF

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