Cleared Traditional

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS

K052525 · DFI Co., Ltd. · Chemistry
Mar 2006
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K052525 is an FDA 510(k) clearance for the CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by DFI Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on March 29, 2006, 196 days after receiving the submission on September 14, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K052525 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2005
Decision Date March 29, 2006
Days to Decision 196 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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