FDA 510(k)

Xprecia Prime Coagulation System

Номер K: K230802 · 2024-03-15

Дата решения2024-03-15

Код продуктаGJS

Консультативный комитетHE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GJS)

K253188CoaguChek XS Plus SystemRoche Diagnostics K251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories K231711microINR SystemIline Microsystems, S.L.K211485STA- NeoPTimalDiagnostica Stago S.A.S

Официальный источник

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