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FDA 510(k)

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

K-Number: K093861 · 2010-02-05

ApplicantIris International, Inc.
Decision Date2010-02-05
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE is the device name listed in this FDA 510(k) record. The listed applicant is Iris International, Inc.. It received FDA 510(k) clearance on 2010-02-05 under 510(k) number K093861. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE?

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE is a medical device that received FDA 510(k) clearance on 2010-02-05. The listed applicant is Iris International, Inc.. The 510(k) number is K093861.

When did IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE receive FDA 510(k) clearance?

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE received FDA 510(k) clearance on 2010-02-05, under 510(k) number K093861.

Who is the listed applicant for IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE?

The FDA 510(k) record lists Iris International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE?

The FDA product code for IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE is LKM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Iris International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060280ICHEM 100 URINE CHEMISTRY ANALYZERK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULE

Related Devices (Code: LKM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252580iQ200 SeriesBeckman Coulter, Inc.K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc.K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.K200811cobas u 701 microscopy analyzerRoche DiagnosticsK171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.K083002SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZERSysmex America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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