FDA 510(k)

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

Номер K: K242294 · 2025-05-09

Дата решения2025-05-09

Код продуктаPTF

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is the device name listed in this FDA 510(k) record. The listed applicant is Diasys Diagnostic Systems GmbH. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K242294. The device is classified under product code PTF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Diasys Diagnostic Systems GmbH. The 510(k) number is K242294.

When did DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls receive FDA 510(k) clearance?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242294.

Who is the listed applicant for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

The FDA 510(k) record lists Diasys Diagnostic Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

The FDA product code for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is PTF.

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: PTF)

K222996Access PCTBeckman Coulter, Inc.K192271Access PCT, Access PCT КалибраторыBeckman Coulter, Inc.K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetDiazyme Laboratories

Официальный источник

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