DIP/U.S. Urine Analysis Test System

Q: What is the product code of K173327?

The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.

FDA 510(k) K173327 · Healthy.Io, Ltd.

Substantially Equivalent

510(k) numberK173327

Submission

Device name: DIP/U.S. Urine Analysis Test System
Applicant: Healthy.Io, Ltd.
Tel Aviv, IL
Received: October 20, 2017
Decision date: July 18, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1340
Specialty: Clinical Chemistry

Other 510(k)s with product code JIL

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K180356	inui In-Home Urine Analysis Test SystemJIL · Traditional	Scanadu, Inc.	05/25/2018SE
K181024	DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional	DFI Co., Ltd.	05/23/2018SE
K171521	DUS R-50S (Urine Chemistry system)JIL · Traditional	DFI Co., Ltd.	02/16/2018SE
K171083	iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional	Iris Diagnostics, A Division of Iris…	05/12/2017SE
K160062	AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional	Arkray, Inc.	10/07/2016SE
K160372	Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional	Teco Diagnostics, Inc.	07/22/2016SE
K141289	Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional	Teco Diagnostics	07/24/2015SE
K131600	URS-2GP (Glucose Protein) Urine StripsJIL · Traditional	Teco Diagnostics	05/29/2014SE

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K210069	Minuteful - kidney testJIR · Traditional	07/06/2022SE
K182384	ACR LAB Urine Analysis Test SystemJFY · Traditional	07/26/2019SE

Questions and answers

When was DIP/U.S. Urine Analysis Test System cleared by the FDA?

DIP/U.S. Urine Analysis Test System (K173327) received a 510(k) decision of Substantially Equivalent on July 18, 2018, 271 days after the submission was received.

What is the product code of K173327?

The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.