Cleared Traditional

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

K101673 · Teco Diagnostics · Chemistry
Feb 2011
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K101673 is an FDA 510(k) clearance for the URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10, 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 February 4, 2011, 234 days after receiving the submission on June 15, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K101673 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2010
Decision Date February 04, 2011
Days to Decision 234 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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