URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer— 510(k) K182038

Name: FDA 510(k) clearance K182038
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Substantially Equivalent

Yd Diagnostics Corporation

FDA 510(k) clearance K182038 for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer, Substantially Equivalent on 2018-12-10. Applicant: Yd Diagnostics Corporation. Device class: 2.

Clearance details

Applicant: Yd Diagnostics Corporation
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2018-07-30
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFY

view all

K252619 — QSCHECK UISACR2026-02-20
K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)2021-11-24
K193649 — Yumizen C1200 Creatinine PAP2021-05-10
K182384 — ACR LAB Urine Analysis Test System2019-07-26
K183555 — GEM Premier ChemSTAT2019-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.