THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY— 510(k) K934539

Name: FDA 510(k) clearance K934539
Creator: U.S. Food and Drug Administration
Published: 1994-03-30

Substantially Equivalent

Intl. Remote Imaging Systems

FDA 510(k) clearance K934539 for THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY, Substantially Equivalent on 1994-03-30. Applicant: Intl. Remote Imaging Systems. Device class: 2.

Clearance details

Applicant: Intl. Remote Imaging Systems
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1993-09-17
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

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