Cleared Traditional

IQ 200 URINE ANALYZER BODY FLUIDS MODULE

K050235 · Iris International, Inc. · Hematology

Mar 2005

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K050235 is an FDA 510(k) clearance for the IQ 200 URINE ANALYZER BODY FLUIDS MODULE, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 23, 2005, 50 days after receiving the submission on February 1, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number	K050235 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2005
Decision Date	March 23, 2005
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF