Cleared Traditional

Scanostics UTI Check Application Test System

K170118 · Teco Diagnostics · Chemistry
Sep 2017
Decision
251d
Days
Class 1
Risk

About This 510(k) Submission

K170118 is an FDA 510(k) clearance for the Scanostics UTI Check Application Test System, a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I — General Controls, product code JMT), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on September 21, 2017, 251 days after receiving the submission on January 13, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1510.

Submission Details

510(k) Number K170118 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2017
Decision Date September 21, 2017
Days to Decision 251 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMT — Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1510

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