FDA 510(k)

IDS-iSYS 適應症檢測儀器

K 號：K200475 · 2020-09-30

決定日期2020-09-30

產品代碼CIN

諮詢委員會CH

決定相當於

器材摘要

IDS-iSYS Ostase BAP 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 2020-09-30 under 510(k) number K200475. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDS-iSYS Ostase BAP?

IDS-iSYS Ostase BAP is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K200475.

When did IDS-iSYS Ostase BAP receive FDA 510(k) clearance?

IDS-iSYS Ostase BAP received FDA 510(k) clearance on 2020-09-30, under 510(k) number K200475.

Who is the listed applicant for IDS-iSYS Ostase BAP?

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 Ostase BAP?

The FDA product code for IDS-iSYS Ostase BAP is CIN.

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

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K202136IDS皮質醇 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：CIN）

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。

K232904Access鹼性磷酸酶Beckman Coulter

官方來源

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