FDA 510(k)

Xprecia Prime Coagulation System

Número K: K230802 · 2024-03-15

RequerenteUniversal Biosensors Pty, Ltd.

Data da decisão2024-03-15

Código do produtoGJS

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xprecia Prime Coagulation System is the device name listed in this FDA 510(k) record. The listed applicant is Universal Biosensors Pty, Ltd.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K230802. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Xprecia Prime Coagulation System?

Xprecia Prime Coagulation System is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Universal Biosensors Pty, Ltd.. The 510(k) number is K230802.

When did Xprecia Prime Coagulation System receive FDA 510(k) clearance?

Xprecia Prime Coagulation System received FDA 510(k) clearance on 2024-03-15, under 510(k) number K230802.

Who is the listed applicant for Xprecia Prime Coagulation System?

The FDA 510(k) record lists Universal Biosensors Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xprecia Prime Coagulation System?

The FDA product code for Xprecia Prime Coagulation System is GJS.

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Fonte oficial

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