FDA 510(k)

iChemVELOCITY Automated Urine Chemistry System

Номер K: K171083 · 2017-05-12

ЗаявительIris Diagnostics, A Division of Iris International, Inc.

Дата решения2017-05-12

Код продуктаJIL

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

iChemVELOCITY Automated Urine Chemistry System is the device name listed in this FDA 510(k) record. The listed applicant is Iris Diagnostics, A Division of Iris International, Inc.. It received FDA 510(k) clearance on 2017-05-12 under 510(k) number K171083. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the iChemVELOCITY Automated Urine Chemistry System?

iChemVELOCITY Automated Urine Chemistry System is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Iris Diagnostics, A Division of Iris International, Inc.. The 510(k) number is K171083.

When did iChemVELOCITY Automated Urine Chemistry System receive FDA 510(k) clearance?

iChemVELOCITY Automated Urine Chemistry System received FDA 510(k) clearance on 2017-05-12, under 510(k) number K171083.

Who is the listed applicant for iChemVELOCITY Automated Urine Chemistry System?

The FDA 510(k) record lists Iris Diagnostics, A Division of Iris International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iChemVELOCITY Automated Urine Chemistry System?

The FDA product code for iChemVELOCITY Automated Urine Chemistry System is JIL.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: JIL)

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, 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.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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