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FDA 510(k)

SYSMEX R-500

K-Number: K001683 · 2000-08-21

ApplicantSysmex Corporation of America
Decision Date2000-08-21
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX R-500 is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corporation of America. It received FDA 510(k) clearance on 2000-08-21 under 510(k) number K001683. 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 SYSMEX R-500?

SYSMEX R-500 is a medical device that received FDA 510(k) clearance on 2000-08-21. The listed applicant is Sysmex Corporation of America. The 510(k) number is K001683.

When did SYSMEX R-500 receive FDA 510(k) clearance?

SYSMEX R-500 received FDA 510(k) clearance on 2000-08-21, under 510(k) number K001683.

Who is the listed applicant for SYSMEX R-500?

The FDA 510(k) record lists Sysmex Corporation of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSMEX R-500?

The FDA product code for SYSMEX R-500 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 Sysmex Corporation of America 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.

K021241SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800IK020496HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY

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.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE 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.

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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