DeviceClearance

Product code GKB— Hematology

SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED

Classification name
Device, Automated Sedimentation Rate
Device class
Class 1
Regulation
21 CFR 864.5800
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

Market context for product code GKB

FDA has cleared 2 devices under product code GKB, all in 1989, 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 GKB

Recent clearances under product code GKB

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