FDA 510(k)

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

Номер K: K173202 · 2018-05-09

Дата решения2018-05-09

Код продуктаJPA

Консультативный комитетHE

РешениеSubstantially Equivalent

Описание устройства

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-09 under 510(k) number K173202. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Sekisui Medical Co., Ltd.. The 510(k) number is K173202.

When did CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set receive FDA 510(k) clearance?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set received FDA 510(k) clearance on 2018-05-09, under 510(k) number K173202.

Who is the listed applicant for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

The FDA 510(k) record lists Sekisui Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

The FDA product code for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is JPA.

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: JPA)

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation K233790ACL TOP 970 CLInstrumentation Laboratory

Официальный источник

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