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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 the device name listed in this FDA 510(k) record. The listed applicant is DFI Co., Ltd.. It received FDA 510(k) clearance on 2018-05-23 under 510(k) 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. The listed applicant is DFI Co., Ltd.. The 510(k) number is K181024.

When did DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips receive FDA 510(k) clearance?

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

Who is the listed applicant for DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips?

The FDA 510(k) record lists DFI Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing DFI Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171521DUS R-50S (Urine Chemistry system)

Related Devices (Code: JIL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/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.K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.

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.

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