Cleared Traditional

DUS R-50S (Urine Chemistry system)

K171521 · DFI Co., Ltd. · Chemistry
Feb 2018
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K171521 is an FDA 510(k) clearance for the DUS R-50S (Urine Chemistry system), a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by DFI Co., Ltd. (Gyeongsangnam-Do, KR). The FDA issued a Cleared decision on February 16, 2018, 268 days after receiving the submission on May 24, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K171521 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2017
Decision Date February 16, 2018
Days to Decision 268 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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