FDA 510(k)

XW-100 Automated Hematology Analyzer for CLIA Waived Use

Número K: K172604 · 2017-11-06

Data da decisão2017-11-06

Código do produtoGKZ

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

XW-100 Automated Hematology Analyzer for CLIA Waived Use 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 2017-11-06 under 510(k) number K172604. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the XW-100 Automated Hematology Analyzer for CLIA Waived Use?

XW-100 Automated Hematology Analyzer for CLIA Waived Use is a medical device that received FDA 510(k) clearance on 2017-11-06. The listed applicant is Sysmex America, Inc.. The 510(k) number is K172604.

When did XW-100 Automated Hematology Analyzer for CLIA Waived Use receive FDA 510(k) clearance?

XW-100 Automated Hematology Analyzer for CLIA Waived Use received FDA 510(k) clearance on 2017-11-06, under 510(k) number K172604.

Who is the listed applicant for XW-100 Automated Hematology Analyzer for CLIA Waived Use?

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 XW-100 Automated Hematology Analyzer for CLIA Waived Use?

The FDA product code for XW-100 Automated Hematology Analyzer for CLIA Waived Use is GKZ.

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Outros registros que listam Sysmex America, Inc. como candidato(a)

K253212XR-Series (XR-10, XR-20) Automated Hematology Analyzers K251371Sysmex XR-Series (XR-20) Automated Hematology Analyzer K250943Sysmex XR-Series (XR-10) Automated Hematology Analyzer K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)K230887Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer K210346Sysmex XW-100 Automated Hematology Analyzer

Ver todos os 12 dispositivos →

Dispositivos Relacionados (Código: GKZ)

K260781Yumizen H550HORIBA ABX SAS K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.

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