FDA 510(k)

AFIAS iFOB 配 AFIAS-50

K 號：K163225 · 2017-08-08

決定日期2017-08-08

產品代碼OOX

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

AFIAS iFOB with AFIAS-50 is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K163225. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AFIAS iFOB with AFIAS-50?

AFIAS iFOB with AFIAS-50 is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Immunostics Inc.,. The 510(k) number is K163225.

When did AFIAS iFOB with AFIAS-50 receive FDA 510(k) clearance?

AFIAS iFOB with AFIAS-50 received FDA 510(k) clearance on 2017-08-08, under 510(k) number K163225.

Who is the listed applicant for AFIAS iFOB with AFIAS-50?

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 AFIAS iFOB with AFIAS-50?

The FDA product code for AFIAS iFOB with AFIAS-50 is OOX.

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 K171484hema-screen 特定金屬金 K163554hema-screen ER XCEL 高解析度隱血便測試

相關器械（代碼：OOX）

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。

K200754Hemosure Accu-Reader A100W.H.P.M., Inc.K191147OC-Auto感測器 io iFOB測試Eiken Chemical Co., Ltd.

官方來源

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