URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

FDA 510(k) K182038 · Yd Diagnostics Corporation

Substantially Equivalent

510(k) numberK182038

Submission

Device name
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Applicant
Yd Diagnostics Corporation
Yongin-Si, KR
Received
July 30, 2018
Decision date
December 10, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JFY – Enzymatic Method, Creatinine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1225
Specialty
Clinical Chemistry

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Questions and answers

When was URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer cleared by the FDA?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (K182038) received a 510(k) decision of Substantially Equivalent on December 10, 2018, 133 days after the submission was received.

What is the product code of K182038?

The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.