Cleared Traditional

YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY

K954006 · Intl. Remote Imaging Systems · Hematology
Mar 1996
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K954006 is an FDA 510(k) clearance for the YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on March 12, 1996, 200 days after receiving the submission on August 25, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K954006 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1995
Decision Date March 12, 1996
Days to Decision 200 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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