Cleared Traditional

900UDX URINE PATHOLOGY SYSTEM

K960054 · Intl. Remote Imaging Systems · Hematology
Mar 1996
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K960054 is an FDA 510(k) clearance for the 900UDX URINE PATHOLOGY SYSTEM, 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 March 22, 1996, 78 days after receiving the submission on January 4, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K960054 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1996
Decision Date March 22, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
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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