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FDA 510(k)

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

K-Number: K181024 · 2018-05-23

ApplicantDFI Co., Ltd.
Decision Date2018-05-23
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips is a medical device manufactured by DFI Co., Ltd.. It received FDA 510(k) clearance on 2018-05-23 under approval number K181024. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips?

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips is a medical device that received FDA 510(k) clearance on 2018-05-23. It is manufactured by DFI Co., Ltd.. The 510(k) number is K181024.

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

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips received FDA 510(k) clearance on 2018-05-23, under approval number K181024.

What company makes DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips?

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips is manufactured by DFI Co., Ltd..

What is the FDA product code for DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips?

The FDA product code for DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips is JIL.

Other Devices by DFI Co., Ltd.

K171521DUS R-50S (Urine Chemistry system)

Related Devices (Code: JIL)

K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. K160372URITEK TC-201 URINE CHEMISTRY TEST SYSTEMTeco Diagnostics, Inc. K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. K180356inui In-Home Urine Analysis Test SystemScanadu, Inc. K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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