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FDA 510(k)

SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER

K-Number: K992875 · 1999-11-09

ApplicantSysmex Corp.
Decision Date1999-11-09
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corp.. It received FDA 510(k) clearance on 1999-11-09 under 510(k) number K992875. 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 XE-2100, AUTOMATATED HEMATOLOGY ANALYZER?

SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1999-11-09. The listed applicant is Sysmex Corp.. The 510(k) number is K992875.

When did SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1999-11-09, under 510(k) number K992875.

Who is the listed applicant for SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER?

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

What is the FDA product code for SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER?

The FDA product code for SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER is GKZ.

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Other records listing Sysmex Corp. 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.

K012372SYSMEX UF-50K981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERK971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERK964946SYSMEX CA-1000/SYSMEX CA-5000K964375SYSMEX SE/RAM-1

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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

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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