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FDA 510(k)

SYSMEX XN-SERIES

K-Number: K112605 · 2012-10-19

ApplicantSysmex America, Inc.
Decision Date2012-10-19
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX XN-SERIES 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 2012-10-19 under 510(k) number K112605. 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 XN-SERIES?

SYSMEX XN-SERIES is a medical device that received FDA 510(k) clearance on 2012-10-19. The listed applicant is Sysmex America, Inc.. The 510(k) number is K112605.

When did SYSMEX XN-SERIES receive FDA 510(k) clearance?

SYSMEX XN-SERIES received FDA 510(k) clearance on 2012-10-19, under 510(k) number K112605.

Who is the listed applicant for SYSMEX XN-SERIES?

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 XN-SERIES?

The FDA product code for SYSMEX XN-SERIES 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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