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FDA 510(k)

ACTIVE® 游離睾酮放免測定

K 號：K191350 · 2019-12-20

申請人Immunotech S.R.O.
決定日期2019-12-20
產品代碼CDZ
諮詢委員會CH
決定相當於

器材摘要

ACTIVE® Free Testosterone RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech S.R.O.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191350. 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 ACTIVE® Free Testosterone RIA?

ACTIVE® Free Testosterone RIA is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Immunotech S.R.O.. The 510(k) number is K191350.

When did ACTIVE® Free Testosterone RIA receive FDA 510(k) clearance?

ACTIVE® Free Testosterone RIA received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191350.

Who is the listed applicant for ACTIVE® Free Testosterone RIA?

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

What is the FDA product code for ACTIVE® Free Testosterone RIA?

The FDA product code for ACTIVE® Free Testosterone RIA is CDZ.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K252728IDS-iSYS 全總壓力測試Immunodiagnostic Systems LimitedK240865IDS-iSYS 自由濃度睪固酮Immunodiagnostic Systems LimitedK233480Access性激素結合球蛋白Beckman Coulter, Inc.K223405Access睪固酮Beckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON 雄激素 xtDiaSorin, Inc.

官方來源

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