Cleared Traditional

939UDX URINE PATHOLOGY SYSTEM

K000373 · Intl. Remote Imaging Systems · Pathology
Apr 2000
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K000373 is an FDA 510(k) clearance for the 939UDX URINE PATHOLOGY 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 April 14, 2000, 70 days after receiving the submission on February 4, 2000. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K000373 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2000
Decision Date April 14, 2000
Days to Decision 70 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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