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FDA 510(k)

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)

K-Number: K040073 · 2004-03-18

ApplicantSysmex America, Inc.
Decision Date2004-03-18
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2004-03-18 under 510(k) number K040073. 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 AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)?

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Sysmex America, Inc.. The 510(k) number is K040073.

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

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) received FDA 510(k) clearance on 2004-03-18, under 510(k) number K040073.

Who is the listed applicant for SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)?

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

What is the FDA product code for SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)?

The FDA product code for SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) is GKZ.

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Other records listing Sysmex America, 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.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersK250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerK251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerK250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerK210346Sysmex XW-100 Automated Hematology Analyzer

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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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