FDA 510(k)

C-Reactive Protein Kit for use on SPAPLUS

Номер K: K161982 · 2017-04-05

Дата решения2017-04-05

Код продуктаDCN

Консультативный комитетIM

РешениеSubstantially Equivalent

Описание устройства

C-Reactive Protein Kit for use on SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K161982. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the C-Reactive Protein Kit for use on SPAPLUS?

C-Reactive Protein Kit for use on SPAPLUS is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is The Binding Site Group. The 510(k) number is K161982.

When did C-Reactive Protein Kit for use on SPAPLUS receive FDA 510(k) clearance?

C-Reactive Protein Kit for use on SPAPLUS received FDA 510(k) clearance on 2017-04-05, under 510(k) number K161982.

Who is the listed applicant for C-Reactive Protein Kit for use on SPAPLUS?

The FDA 510(k) record lists The Binding Site Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-Reactive Protein Kit for use on SPAPLUS?

The FDA product code for C-Reactive Protein Kit for use on SPAPLUS is DCN.

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: DCN)

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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