Cleared Traditional

URS-IG (GLUCOSE TEST)

K020175 · Teco Diagnostics · Chemistry
Mar 2002
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K020175 is an FDA 510(k) clearance for the URS-IG (GLUCOSE TEST), 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 March 21, 2002, 63 days after receiving the submission on January 17, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K020175 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2002
Decision Date March 21, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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