FDA 510(k)

連續單一培養-NX完整版（CSCM-NXC）

K 號：K170602 · 2017-06-07

決定日期2017-06-07

產品代碼MQL

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Continuous Single Culture-NX Complete (CSCM-NXC) is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K170602. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Continuous Single Culture-NX Complete (CSCM-NXC)?

Continuous Single Culture-NX Complete (CSCM-NXC) is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K170602.

When did Continuous Single Culture-NX Complete (CSCM-NXC) receive FDA 510(k) clearance?

Continuous Single Culture-NX Complete (CSCM-NXC) received FDA 510(k) clearance on 2017-06-07, under 510(k) number K170602.

Who is the listed applicant for Continuous Single Culture-NX Complete (CSCM-NXC)?

The FDA 510(k) record lists Irvine Scientific Sales Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Continuous Single Culture-NX Complete (CSCM-NXC)?

The FDA product code for Continuous Single Culture-NX Complete (CSCM-NXC) is MQL.

其他以 Irvine Scientific Sales Co., Inc. 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。

K171224Arctic Sperm 冷凍保存劑 K170681連續單一培養 -NX (CSCM-NX)

相關器械（代碼：MQL）

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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