FDA 510(k)

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

K番号: K163554 · 2017-01-17

決定日2017-01-17

製品コードKHE

諮問委員会HE社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書に基づいて承認されており、PMA（プレマーケティング評価）やNCT（臨床試験登録番号）、PMID（PubMed ID）などの識別情報も提供されています。詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてImmunostics Inc.,を記載するその他の記録

K221817ALFISビタミンD、ALFIS-3アナライザー K182298hemochroma PLUS System K163465hemochroma PLUS System K163225AFIAS iFOB with AFIAS-50 K171484hema-screen SPECIFIC Gold

公式ソース

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