FDA 510(k)

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

Número K: K181024 · 2018-05-23

Data da decisão2018-05-23

Código do produtoJIL

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam DFI Co., Ltd. como candidato(a)

K171521DUS R-50S (Urine Chemistry system)

Dispositivos Relacionados (Código: JIL)

K193514SISTEMA DE ANÁLISE DE URINA AUTION MAX AX-4060Arkray, Inc.K183432cobas u 601 urinalysis test systemRoche Diagnostics 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.K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.

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