FDA 510(k)

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

Номер K: K171498 · 2018-01-12

Дата решения2018-01-12

Код продуктаDCN

Консультативный комитетIM

РешениеSubstantially Equivalent

Описание устройства

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Meso Scale Diagnostics, LLC. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171498. 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 MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Meso Scale Diagnostics, LLC. The 510(k) number is K171498.

When did MSD CRP Assay Kit and MESO SECTOR S 700 Instrument receive FDA 510(k) clearance?

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171498.

Who is the listed applicant for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

The FDA 510(k) record lists Meso Scale Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

The FDA product code for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.