ACR LAB Urine Analysis Test System

Q: What is the product code of K182384?

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

FDA 510(k) K182384 · Healthy.Io, Ltd.

Substantially Equivalent

510(k) numberK182384

Submission

Device name: ACR LAB Urine Analysis Test System
Applicant: Healthy.Io, Ltd.
Tel Aviv, IL
Received: August 31, 2018
Decision date: July 26, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code JFY

510(k)	Device	Applicant	Decision
K252619	Qscheck UisacrJFY · Traditional	Qstag, Inc.	02/20/2026SE
K212223	Atellica CH Enzymatic Creatinine_3 (ECre3)JFY · Traditional	Siemens Healthcare Diagnostics, Inc.	11/24/2021SE
K193649	Yumizen C1200 Creatinine PAPJFY · Traditional	Horiba Abx SAS	05/10/2021SE
K183555	GEM Premier ChemSTATJFY · Traditional	Instrumentation Laboratory CO	02/16/2019SE
K182038	URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerJFY · Traditional	Yd Diagnostics Corporation	12/10/2018SE
K182063	VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…JFY · Traditional	Ortho-Clinical Diagnostics, Inc.	10/30/2018SE
K161527	Teco Creatinine Enzymatic Reagent KitJFY · Traditional	Teco Diagnostics, Inc.	07/21/2017SE
K152835	Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional	Teco Diagnostics, Inc.	03/07/2016SE
K142391	Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…JFY · Traditional	ACON Laboratories, Inc.	12/22/2014SE
K132399	Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…JFY · Traditional	Elitechgroup	01/03/2014SE

More from Elitechgroup

510(k)	Device	Decision
K222921	Minuteful-kidney testJIR · Traditional	09/08/2023SE
K210069	Minuteful - kidney testJIR · Traditional	07/06/2022SE
K173327	DIP/U.S. Urine Analysis Test SystemJIL · Traditional	07/18/2018SE

Questions and answers

When was ACR LAB Urine Analysis Test System cleared by the FDA?

ACR LAB Urine Analysis Test System (K182384) received a 510(k) decision of Substantially Equivalent on July 26, 2019, 329 days after the submission was received.

What is the product code of K182384?

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