Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle

Q: What is the product code of K093861?

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

FDA 510(k) K093861 · Iris International, Inc.

Substantially Equivalent

510(k) numberK093861

Submission

Device name: Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle
Applicant: Iris International, Inc.
Chatsworth, CA, US
Received: December 16, 2009
Decision date: February 5, 2010
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LKM – Counter, Urine Particle
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.5200
Specialty: Hematology

Other 510(k)s with product code LKM

510(k)	Device	Applicant	Decision
K252580	iQ200 SeriesLKM · Special	Beckman Coulter, Inc.	09/10/2025SE
K232416	AUTION EYE AI-4510 Urine Particle Analysis SystemLKM · Traditional	Arkray, Inc.	05/03/2024SE
K210127	iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemLKM · Traditional	Beckman Coulter, Inc.	07/02/2021SE
K200811	cobas u 701 microscopy analyzerLKM · Traditional	Roche Diagnostics	11/06/2020SE
K171883	Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional	Sysmex America, Inc.	04/23/2018SE
K083002	Sysmex UF-500I Automated Urine Particle AnalyzerLKM · Special	Sysmex America, Inc.	02/03/2009SE
K080887	Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareLKM · Special	Sysmex America, Inc.	05/02/2008SE
K070910	Sysmex Model UF1000ILKM · Traditional	Sysmex America, Inc.	05/25/2007SE
K053135	Sysmex UF-100I Automated Urine Cell AnalyzerLKM · Traditional	Sysmex America, Inc.	01/04/2006SE
K022774	Iq 200 SystemLKM · Traditional	Intl. Remote Imaging Systems	10/21/2002SE

More from Intl. Remote Imaging Systems

510(k)	Device	Decision
K060280	Ichem 100 Urine Chemistry AnalyzerJIL · Traditional	06/13/2006SE
K050235	Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional	03/23/2005SE

Questions and answers

When was Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle cleared by the FDA?

Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle (K093861) received a 510(k) decision of Substantially Equivalent on February 5, 2010, 51 days after the submission was received.

What is the product code of K093861?

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