Cleared Traditional

URITEK-720+ URINE ANALYZER

K051526 · Teco Diagnostics · Chemistry
Aug 2005
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K051526 is an FDA 510(k) clearance for the URITEK-720+ URINE ANALYZER, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on August 16, 2005, 69 days after receiving the submission on June 8, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K051526 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2005
Decision Date August 16, 2005
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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