Cleared Traditional

iChemVELOCITY Automated Urine Chemistry System

K171083 · Iris Diagnostics, A Division of Iris International, Inc. · Chemistry

May 2017

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K171083 is an FDA 510(k) clearance for the iChemVELOCITY Automated Urine Chemistry System, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Iris Diagnostics, A Division of Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 12, 2017, 31 days after receiving the submission on April 11, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number	K171083 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2017
Decision Date	May 12, 2017
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF