Cleared Special

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

K093861 · Iris International, Inc. · Pathology

Feb 2010

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K093861 is an FDA 510(k) clearance for the IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE, a Counter, Urine Particle (Class II — Special Controls, product code LKM), submitted by Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on February 5, 2010, 51 days after receiving the submission on December 16, 2009. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number	K093861 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2009
Decision Date	February 05, 2010
Days to Decision	51 days
Submission Type	Special
Review Panel	Pathology (PA)
Summary	Summary PDF