DeviceClearance

Product code KSO— Hematology

IMMUFUGE DISP. LINER

Classification name
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Device class
Class 1
Regulation
21 CFR 864.9275
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

Market context for product code KSO

FDA has cleared 1 device under product code KSO, all in 1978, 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 KSO

Recent clearances under product code KSO

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