FDA 510(k)

Audit MicroControls Linearity FD 癌症標記II

K 號：K163629 · 2017-03-10

決定日期2017-03-10

產品代碼JJY

諮詢委員會CH

決定相當於

器材摘要

Audit MicroControls Linearity FD Tumor Markers II is the device name listed in this FDA 510(k) record. The listed applicant is Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163629. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Audit MicroControls Linearity FD Tumor Markers II?

Audit MicroControls Linearity FD Tumor Markers II is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K163629.

When did Audit MicroControls Linearity FD Tumor Markers II receive FDA 510(k) clearance?

Audit MicroControls Linearity FD Tumor Markers II received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163629.

Who is the listed applicant for Audit MicroControls Linearity FD Tumor Markers II?

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

What is the FDA product code for Audit MicroControls Linearity FD Tumor Markers II?

The FDA product code for Audit MicroControls Linearity FD Tumor Markers II is JJY.

其他以 Aalto Scientific, Ltd. 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。

K161874Audit MicroControls Linearity DROP LQ 血糖檢測儀

相關器械（代碼：JJY）

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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