FDA 510(k)

Sysmex Automated Blood Coagulation Analyzer CS-2100i

Número K: K151259 · 2016-01-26

RequerenteSiemens Healthcare Diagnostics Products GmbH

Data da decisão2016-01-26

Código do produtoJPA

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sysmex Automated Blood Coagulation Analyzer CS-2100i is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K151259. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sysmex Automated Blood Coagulation Analyzer CS-2100i?

Sysmex Automated Blood Coagulation Analyzer CS-2100i is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K151259.

When did Sysmex Automated Blood Coagulation Analyzer CS-2100i receive FDA 510(k) clearance?

Sysmex Automated Blood Coagulation Analyzer CS-2100i received FDA 510(k) clearance on 2016-01-26, under 510(k) number K151259.

Who is the listed applicant for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i is JPA.

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