FDA 510(k)

IDS-iSYS 全總壓力測試

K 號：K252728 · 2026-04-15

決定日期2026-04-15

產品代碼CDZ

諮詢委員會CH

決定相當於

器材摘要

IDS-iSYS Total Testosterone is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems Limited. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K252728. 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-iSYS Total Testosterone?

IDS-iSYS Total Testosterone is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Immunodiagnostic Systems Limited. The 510(k) number is K252728.

When did IDS-iSYS Total Testosterone receive FDA 510(k) clearance?

IDS-iSYS Total Testosterone received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252728.

Who is the listed applicant for IDS-iSYS Total Testosterone?

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

What is the FDA product code for IDS-iSYS Total Testosterone?

The FDA product code for IDS-iSYS Total Testosterone is CDZ.

其他以 Immunodiagnostic Systems Limited 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。

K240865IDS-iSYS 自由濃度睪固酮 K223867IDS ACTH II

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。

K240865IDS-iSYS 自由濃度睪固酮Immunodiagnostic Systems Limited K233480Access性激素結合球蛋白Beckman Coulter, Inc.K223405Access睪固酮Beckman Coulter, Inc.K211685Elecsys Testosterone IIRoche Diagnostics K201908LIAISON 雄激素 xtDiaSorin, Inc.K191350ACTIVE® 游離睾酮放免測定Immunotech S.R.O.

官方來源

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