Cleared Traditional

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

K182038 · Yd Diagnostics Corporation · Chemistry

Dec 2018

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K182038 is an FDA 510(k) clearance for the URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Yd Diagnostics Corporation (Yongin-Si, KR). The FDA issued a Cleared decision on December 10, 2018, 133 days after receiving the submission on July 30, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K182038 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2018
Decision Date	December 10, 2018
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement