Cleared Traditional

ICHEM 100 URINE CHEMISTRY ANALYZER

K060280 · Iris International, Inc. · Chemistry

Jun 2006

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K060280 is an FDA 510(k) clearance for the ICHEM 100 URINE CHEMISTRY ANALYZER, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 13, 2006, 131 days after receiving the submission on February 2, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number	K060280 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2006
Decision Date	June 13, 2006
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF