Cleared Traditional

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

K160372 · Teco Diagnostics, Inc. · Chemistry
Jul 2016
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K160372 is an FDA 510(k) clearance for the URITEK TC-201 URINE CHEMISTRY TEST SYSTEM, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Teco Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 22, 2016, 163 days after receiving the submission on February 10, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K160372 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2016
Decision Date July 22, 2016
Days to Decision 163 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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