FDA 510(k)

生物流設備

K 號：K172311 · 2017-12-15

決定日期2017-12-15

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

BioFlux Device is the device name listed in this FDA 510(k) record. The listed applicant is Biotricity, Inc.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172311. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the BioFlux Device?

BioFlux Device is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Biotricity, Inc.. The 510(k) number is K172311.

When did BioFlux Device receive FDA 510(k) clearance?

BioFlux Device received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172311.

Who is the listed applicant for BioFlux Device?

The FDA 510(k) record lists Biotricity, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioFlux Device?

The FDA product code for BioFlux Device is DXH. This falls under the Hematology category.

其他以 Biotricity, Inc. 為申請人之記錄

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K162571生物流軟體

相關器械（代碼：DXH）

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