FDA 510(k)

IDS皮質醇

K 號：K202136 · 2021-04-13

決定日期2021-04-13

產品代碼CGR

諮詢委員會CH

決定相當於

器材摘要

IDS Cortisol 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 2021-04-13 under 510(k) number K202136. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDS Cortisol?

IDS Cortisol is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K202136.

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

IDS Cortisol received FDA 510(k) clearance on 2021-04-13, under 510(k) number K202136.

Who is the listed applicant for IDS Cortisol?

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 Cortisol?

The FDA product code for IDS Cortisol is CGR.

其他以 Immunodiagnostic Systems , 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。

K200475IDS-iSYS 適應症檢測儀器 K190121IDS SHBG K161158IDS-iSYS 完整PTHN K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs 控制組 K161082IDS-iSYS 17-OH 孕酮控制組，IDS-iSYS 17-OH 孕酮校準驗證器

相關器械（代碼：CGR）

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。

K242190Access 腺皮質醇；DxC 500i臨床分析儀Beckman Coulter, Inc.K223038Access 腺皮質醇Beckman Coulter, Inc.K202826IMMULITE® 2000 皮質醇Siemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 皮質醇Siemens Healthcare Diagnostics Products, Ltd.

官方來源

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