FDA 510(k)

Hipro Glycosylated Hemoglobin (HbA1c) Test System

Номер K: K220999 · 2024-09-12

ЗаявительShijiazhuang Hipro Biotechnology Co., Ltd.

Дата решения2024-09-12

Код продуктаPDJ

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

Hipro Glycosylated Hemoglobin (HbA1c) Test System is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Hipro Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K220999. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Hipro Glycosylated Hemoglobin (HbA1c) Test System?

Hipro Glycosylated Hemoglobin (HbA1c) Test System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Shijiazhuang Hipro Biotechnology Co., Ltd.. The 510(k) number is K220999.

When did Hipro Glycosylated Hemoglobin (HbA1c) Test System receive FDA 510(k) clearance?

Hipro Glycosylated Hemoglobin (HbA1c) Test System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K220999.

Who is the listed applicant for Hipro Glycosylated Hemoglobin (HbA1c) Test System?

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

What is the FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System?

The FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System is PDJ.

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: PDJ)

K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA Химия Энзиматический Гемоглобин Ale (Alc_E) АнализSiemens Healthcare Diagnostics, Inc.K193053Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics Operations (Rdo)

Официальный источник

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