iChemVELOCITY Automated Urine Chemistry System— 510(k) K171083

Name: FDA 510(k) clearance K171083
Creator: U.S. Food and Drug Administration
Published: 2017-05-12

Substantially Equivalent

Iris Diagnostics, A Division of Iris International, Inc.

FDA 510(k) clearance K171083 for iChemVELOCITY Automated Urine Chemistry System, Substantially Equivalent on 2017-05-12. Applicant: Iris Diagnostics, A Division of Iris International, Inc.. Device class: 2.

Clearance details

Applicant: Iris Diagnostics, A Division of Iris International, Inc.
Product code: Product code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2017-04-11
Decision date: 2017-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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