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FDA 510(k)

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

K-Number: K021241 · 2002-06-25

ApplicantSysmex Corporation of America
Decision Date2002-06-25
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I 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 2002-06-25 under 510(k) number K021241. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I?

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I is a medical device that received FDA 510(k) clearance on 2002-06-25. The listed applicant is Sysmex Corporation of America. The 510(k) number is K021241.

When did SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I receive FDA 510(k) clearance?

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I received FDA 510(k) clearance on 2002-06-25, under 510(k) number K021241.

Who is the listed applicant for SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I?

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 XT-SERIES, MODEL XT-2000I AND XT-1800I?

The FDA product code for SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I is GKZ.

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 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.

K020496HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGYK001683SYSMEX R-500

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology 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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