FDA 510(k)

即時視覺-PLUS 免疫化學糞便隱血測試

K 號：K173212 · 2018-02-15

決定日期2018-02-15

產品代碼KHE

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Instant-view-PLUS immunochemical Fecal Occult Blood Test is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2018-02-15 under 510(k) number K173212. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Instant-view-PLUS immunochemical Fecal Occult Blood Test?

Instant-view-PLUS immunochemical Fecal Occult Blood Test is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K173212.

When did Instant-view-PLUS immunochemical Fecal Occult Blood Test receive FDA 510(k) clearance?

Instant-view-PLUS immunochemical Fecal Occult Blood Test received FDA 510(k) clearance on 2018-02-15, under 510(k) number K173212.

Who is the listed applicant for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

FDA 510(k) 記錄將 Alfa Scientific Designs, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

The FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test is KHE.

其他以 Alfa Scientific Designs, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：KHE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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