FDA 510(k)

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

N.º K: K181024 · 2018-05-23

Fecha de decisión2018-05-23

Código de productoJIL

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a DFI Co., Ltd. como solicitante

K171521DUS R-50S (Urine Chemistry system)

Dispositivos relacionados (Código: JIL)

K193514SISTEMA DE ANÁLISIS DE ORINA 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.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.