Cleared Traditional

IQ 200 SYSTEM

K022774 · Intl. Remote Imaging Systems · Pathology
Oct 2002
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K022774 is an FDA 510(k) clearance for the IQ 200 SYSTEM, a Counter, Urine Particle (Class II — Special Controls, product code LKM), submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on October 21, 2002, 61 days after receiving the submission on August 21, 2002. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K022774 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2002
Decision Date October 21, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code LKM — Counter, Urine Particle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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