FDA 510(k)

George King Coumadin Plasma

Номер K: K161316 · 2017-02-23

Дата решения2017-02-23

Код продуктаGGN

Консультативный комитетHE

РешениеSubstantially Equivalent

Описание устройства

George King Coumadin Plasma is the device name listed in this FDA 510(k) record. The listed applicant is George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K161316. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the George King Coumadin Plasma?

George King Coumadin Plasma is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K161316.

When did George King Coumadin Plasma receive FDA 510(k) clearance?

George King Coumadin Plasma received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161316.

Who is the listed applicant for George King Coumadin Plasma?

The FDA 510(k) record lists George King Bio-Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for George King Coumadin Plasma?

The FDA product code for George King Coumadin Plasma is GGN.

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: GGN)

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC K150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, Inc.

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.