Cleared Traditional

URITEK 151 URINE ANALYZER, MODEL TC-151

K042421 · Teco Diagnostics · Chemistry
May 2005
Decision
244d
Days
Class 1
Risk

About This 510(k) Submission

K042421 is an FDA 510(k) clearance for the URITEK 151 URINE ANALYZER, MODEL TC-151, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on May 9, 2005, 244 days after receiving the submission on September 7, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K042421 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2004
Decision Date May 09, 2005
Days to Decision 244 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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