FDA 510(k)

DUS R-50S (Urine Chemistry system)

K-Number: K171521 · 2018-02-16

Decision Date2018-02-16

Product CodeJIL

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DUS R-50S (Urine Chemistry system) is a medical device manufactured by DFI Co., Ltd.. It received FDA 510(k) clearance on 2018-02-16 under approval number K171521. 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 R-50S (Urine Chemistry system)?

DUS R-50S (Urine Chemistry system) is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by DFI Co., Ltd.. The 510(k) number is K171521.

When was DUS R-50S (Urine Chemistry system) approved by the FDA?

DUS R-50S (Urine Chemistry system) received FDA 510(k) clearance on 2018-02-16, under approval number K171521.

What company makes DUS R-50S (Urine Chemistry system)?

DUS R-50S (Urine Chemistry system) is manufactured by DFI Co., Ltd..

What is the FDA product code for DUS R-50S (Urine Chemistry system)?

The FDA product code for DUS R-50S (Urine Chemistry system) is JIL.

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Other Devices by DFI Co., Ltd.

K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

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. K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.

Official Source

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