Cleared Traditional

URS-2GP (GLUCOSE PROTEIN) URINE STRIPS

K131600 · Teco Diagnostics · Chemistry
May 2014
Decision
360d
Days
Class 2
Risk

About This 510(k) Submission

K131600 is an FDA 510(k) clearance for the URS-2GP (GLUCOSE PROTEIN) URINE STRIPS, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on May 29, 2014, 360 days after receiving the submission on June 3, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K131600 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date May 29, 2014
Days to Decision 360 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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