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FDA 510(k)

iChemVELOCITY Automated Urine Chemistry System

K-Number: K171083 · 2017-05-12

ApplicantIris Diagnostics, A Division of Iris International, Inc.
Decision Date2017-05-12
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iChemVELOCITY Automated Urine Chemistry System is a medical device manufactured by Iris Diagnostics, A Division of Iris International, Inc.. It received FDA 510(k) clearance on 2017-05-12 under approval number K171083. 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 iChemVELOCITY Automated Urine Chemistry System?

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

When was iChemVELOCITY Automated Urine Chemistry System approved by the FDA?

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

What company makes iChemVELOCITY Automated Urine Chemistry System?

iChemVELOCITY Automated Urine Chemistry System is manufactured by Iris Diagnostics, A Division of Iris International, Inc..

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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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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