Cleared Traditional

TECO DIAGNOSTICS UTI DETECTION STRIPS

K100024 · Teco Diagnostics · Chemistry
Feb 2011
Decision
408d
Days
Class 1
Risk

About This 510(k) Submission

K100024 is an FDA 510(k) clearance for the TECO DIAGNOSTICS UTI DETECTION STRIPS, 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 February 17, 2011, 408 days after receiving the submission on January 5, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1510.

Submission Details

510(k) Number K100024 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2010
Decision Date February 17, 2011
Days to Decision 408 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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