Cleared Traditional

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

K101852 · Iris International Inc., A Division of Iris Iris I · Chemistry

Mar 2011

Decision

265d

Days

Class 1

Risk

About This 510(k) Submission

K101852 is an FDA 510(k) clearance for the CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Iris International Inc., A Division of Iris Iris I (Chatsworth, US). The FDA issued a Cleared decision on March 23, 2011, 265 days after receiving the submission on July 1, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number	K101852 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2010
Decision Date	March 23, 2011
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF