DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

FDA 510(k) K181024 · DFI Co., Ltd.

Substantially Equivalent

510(k) numberK181024

Submission

Device name
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
Applicant
DFI Co., Ltd.
Gyeongsangnam-Do, KR
Received
April 18, 2018
Decision date
May 23, 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

510(k)DeviceApplicantDecision
K193514AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional Arkray, Inc.04/13/2023SE
K183432cobas u 601 urinalysis test systemJIL · Traditional Roche Diagnostics05/07/2019SE
K173327DIP/U.S. Urine Analysis Test SystemJIL · Traditional Healthy.Io, Ltd.07/18/2018SE
K180356inui In-Home Urine Analysis Test SystemJIL · Traditional Scanadu, Inc.05/25/2018SE
K171521DUS R-50S (Urine Chemistry system)JIL · Traditional DFI Co., Ltd.02/16/2018SE
K171083iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional Iris Diagnostics, A Division of Iris…05/12/2017SE
K160062AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional Arkray, Inc.10/07/2016SE
K160372Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional Teco Diagnostics, Inc.07/22/2016SE
K141289Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional Teco Diagnostics07/24/2015SE
K131600URS-2GP (Glucose Protein) Urine StripsJIL · Traditional Teco Diagnostics05/29/2014SE

More from Teco Diagnostics

510(k)DeviceDecision
K171521DUS R-50S (Urine Chemistry system)JIL · Traditional 02/16/2018SE
K102188Cybow Reader, Models 300 & 720KQO · Traditional 08/09/2011SE
K052525Cybow 11 Series Reagent Strips for UrinalysisJIL · Traditional 03/29/2006SE

Questions and answers

When was DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips cleared by the FDA?

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (K181024) received a 510(k) decision of Substantially Equivalent on May 23, 2018, 35 days after the submission was received.

What is the product code of K181024?

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