FDA 510(k)

IDS-iSYS 完整PTHN

K 號：K161158 · 2017-01-31

決定日期2017-01-31

產品代碼CEW

諮詢委員會CH

決定相當於

器材摘要

IDS-iSYS Intact PTHN 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 2017-01-31 under 510(k) number K161158. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDS-iSYS Intact PTHN?

IDS-iSYS Intact PTHN is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K161158.

When did IDS-iSYS Intact PTHN receive FDA 510(k) clearance?

IDS-iSYS Intact PTHN received FDA 510(k) clearance on 2017-01-31, under 510(k) number K161158.

Who is the listed applicant for IDS-iSYS Intact PTHN?

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-iSYS Intact PTHN?

The FDA product code for IDS-iSYS Intact PTHN is CEW.

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。

K202136IDS皮質醇 K200475IDS-iSYS 適應症檢測儀器 K190121IDS SHBG 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：CEW）

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。

K231927Elecsys PTH，Elecsys PTH STATRoche Diagnostics K232791Access完整PTHBeckman Coulter, Inc.K221197VITROS 免疫診斷產品完整 PTH II 製劑包Ortho Clinical Diagnostics K190702Lumipulse G 全部 PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur 完整副甲状腺激素 (PTH) 檢測Siemens Healthcare Diagnostics, Inc.

官方來源

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