Iq 200 Urine Analyzer Body Fluids Module

FDA 510(k) K050235 · Iris International, Inc.

Substantially Equivalent

510(k) numberK050235

Submission

Device name
Iq 200 Urine Analyzer Body Fluids Module
Applicant
Iris International, Inc.
Chatsworth, CA, US
Received
February 1, 2005
Decision date
March 23, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKL – Counter, Cell, Automated (Particle Counter)
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5200
Specialty
Hematology

Other 510(k)s with product code GKL

510(k)DeviceApplicantDecision
K152776Glocyte Automated Cell Counter SystemGKL · Traditional Advanced Instruments, Inc.05/27/2016SE
K091539Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional Iris Diagnostics08/31/2010SE
K071652Hemocue WBC SystemGKL · Traditional Hemocue AB10/25/2007SE
K051693Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional Bayer Healthcare, LLC12/07/2005SE
K032677Sysmex POCH-100IGKL · Traditional Sysmex America, Inc.02/11/2004SE
K022331Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special Bayer Diagnostics Corp.09/11/2002SE
K001683Sysmex R-500GKL · Traditional Sysmex Corporation of America08/21/2000SE
K991070Coulter Z2 AnalyzerGKL · Traditional Coulter Corp.05/11/1999SE
K981950Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional Sysmex Corp.11/03/1998SE
K981761Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional Sysmex Corp.08/14/1998SE

More from Sysmex Corp.

510(k)DeviceDecision
K093861Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina CradleLKM · Special 02/05/2010SE
K060280Ichem 100 Urine Chemistry AnalyzerJIL · Traditional 06/13/2006SE

Questions and answers

When was Iq 200 Urine Analyzer Body Fluids Module cleared by the FDA?

Iq 200 Urine Analyzer Body Fluids Module (K050235) received a 510(k) decision of Substantially Equivalent on March 23, 2005, 50 days after the submission was received.

What is the product code of K050235?

The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.