510(k) K934539

THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY by Intl. Remote Imaging Systems — Product Code GKL

K934539 is an FDA 510(k) premarket notification submitted by Intl. Remote Imaging Systems for the device "THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY". The FDA issued a decision of Substantially Equivalent on March 30, 1994. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Intl. Remote Imaging Systems has at least 10 other 510(k) clearances on record.