FDA 510(k)

XN-L檢查

K 號：K160586 · 2016-12-22

申請人Streck

決定日期2016-12-22

產品代碼JPK

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

XN-L CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160586. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XN-L CHECK?

XN-L CHECK is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Streck. The 510(k) number is K160586.

When did XN-L CHECK receive FDA 510(k) clearance?

XN-L CHECK received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160586.

Who is the listed applicant for XN-L CHECK?

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

What is the FDA product code for XN-L CHECK?

The FDA product code for XN-L CHECK is JPK.

其他以 Streck 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。

K254166MDx-Chex 適用於BCN K231223MDx-Chex 適用於 BC-GN 医療設備規範文本 K231221MDx-Chex 靈敏測試用於乳癌早期診斷 K170091UA-細胞完整版 K160585XN 藥品設備規範文本 K160588XN檢查BF

查看所有 8 項裝置 →

相關器械（代碼：JPK）

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。

K160588XN檢查BFStreck K160590XN檢查Streck K160606BC-5D 血液學控制儀R&D Systems, Inc.

官方來源

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