FDA 510(k)

iChemVELOCITY Automated Urine Chemistry System

Número K: K171083 · 2017-05-12

RequerenteIris Diagnostics, A Division of Iris International, Inc.

Data da decisão2017-05-12

Código do produtoJIL

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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