FDA 510(k)

hema-screen ER XCEL 高解析度隱血便測試

K 號：K163554 · 2017-01-17

決定日期2017-01-17

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

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-01-17 under 510(k) number K163554. 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 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is a medical device that received FDA 510(k) clearance on 2017-01-17. The listed applicant is Immunostics Inc.,. The 510(k) number is K163554.

When did hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test receive FDA 510(k) clearance?

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test received FDA 510(k) clearance on 2017-01-17, under 510(k) number K163554.

Who is the listed applicant for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

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

What is the FDA product code for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

The FDA product code for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is KHE.

其他以 Immunostics 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。

K221817ALFIS 维生素D，ALFIS-3 分析儀 K182298血液紅素PLUS系統 K163465血液紅素PLUS系統 K163225AFIAS iFOB 配 AFIAS-50 K171484hema-screen 特定金屬金

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。

K173212即時視覺-PLUS 免疫化學糞便隱血測試Alfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen 特定金屬金Immunostics Inc.,K162333Wondfo 一步式糞便隱血（FOB）檢測Guangzhou Wondfo Biotech Co., Ltd.

官方來源

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