Cleared Traditional

THE YELLOW IRIS URINALYSIS WORKSTATION

K972141 · Intl. Remote Imaging Systems · Chemistry
Aug 1997
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K972141 is an FDA 510(k) clearance for the THE YELLOW IRIS URINALYSIS WORKSTATION, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on August 25, 1997, 80 days after receiving the submission on June 6, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K972141 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1997
Decision Date August 25, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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