FDA 510(k)

IDS SHBG

K 號：K190121 · 2019-06-17

決定日期2019-06-17

產品代碼CDZ

諮詢委員會CH

決定相當於

器材摘要

IDS SHBG is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K190121. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDS SHBG?

IDS SHBG is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K190121.

When did IDS SHBG receive FDA 510(k) clearance?

IDS SHBG received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190121.

Who is the listed applicant for IDS SHBG?

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

What is the FDA product code for IDS SHBG?

The FDA product code for IDS SHBG is CDZ.

其他以 Immunodiagnostic Systems , Ltd. 為申請人之記錄

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相關器械（代碼：CDZ）

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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