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FDA 510(k)

IDS-iSYS 17-OH 孕酮控制組，IDS-iSYS 17-OH 孕酮校準驗證器

K 號：K161082 · 2016-05-17

申請人Immunodiagnostic Systems , Ltd.
決定日期2016-05-17
產品代碼JJX
諮詢委員會CH
決定相當於

器材摘要

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers 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 2016-05-17 under 510(k) number K161082. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers?

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K161082.

When did IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers receive FDA 510(k) clearance?

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers received FDA 510(k) clearance on 2016-05-17, under 510(k) number K161082.

Who is the listed applicant for IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers?

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 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers?

The FDA product code for IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers is JJX.

相關臨床試驗

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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。

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相關器械（代碼：JJX）

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。

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官方來源

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