Cleared Traditional

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

K181024 · DFI Co., Ltd. · Chemistry

May 2018

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K181024 is an FDA 510(k) clearance for the DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips, 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 May 23, 2018, 35 days after receiving the submission on April 18, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number	K181024 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2018
Decision Date	May 23, 2018
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF