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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 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.

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. 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.

Related Devices (Code: JIL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/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.

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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