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FDA 510(k)

IQ 200 URINE ANALIZER BODY FLUIDS MODULE

K-Number: K091539 · 2010-08-31

ApplicantIris Diagnostics
Decision Date2010-08-31
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IQ 200 URINE ANALIZER BODY FLUIDS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Iris Diagnostics. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K091539. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQ 200 URINE ANALIZER BODY FLUIDS MODULE?

IQ 200 URINE ANALIZER BODY FLUIDS MODULE is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Iris Diagnostics. The 510(k) number is K091539.

When did IQ 200 URINE ANALIZER BODY FLUIDS MODULE receive FDA 510(k) clearance?

IQ 200 URINE ANALIZER BODY FLUIDS MODULE received FDA 510(k) clearance on 2010-08-31, under 510(k) number K091539.

Who is the listed applicant for IQ 200 URINE ANALIZER BODY FLUIDS MODULE?

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

What is the FDA product code for IQ 200 URINE ANALIZER BODY FLUIDS MODULE?

The FDA product code for IQ 200 URINE ANALIZER BODY FLUIDS MODULE is GKL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Iris Diagnostics 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.

K072640IRISPEC,CA/CB/CC

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.K022331ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHODBayer Diagnostics Corp.

Official Source

View on FDA Database →

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

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