FDA 510(k)

悉尼IVF精子冷凍保護劑

K 號：K160814 · 2016-04-22

申請人William A. Cook Australia Pty. , Ltd.

決定日期2016-04-22

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

Sydney IVF Sperm Cryopreservation Buffer is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160814. 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 Sydney IVF Sperm Cryopreservation Buffer?

Sydney IVF Sperm Cryopreservation Buffer is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K160814.

When did Sydney IVF Sperm Cryopreservation Buffer receive FDA 510(k) clearance?

Sydney IVF Sperm Cryopreservation Buffer received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160814.

Who is the listed applicant for Sydney IVF Sperm Cryopreservation Buffer?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sydney IVF Sperm Cryopreservation Buffer?

The FDA product code for Sydney IVF Sperm Cryopreservation Buffer is MQL.

其他以 William A. Cook Australia Pty. , 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。

K173431Towako 轉宮腔胚胎移植組合 K171611雙腔卵子吸取針 K160753COOK 真空泵 K170257悉尼IVF培養油 K153478悉尼IVF卵子緩冲劑 K152717悉尼IVF胚囊冷凍組合包，悉尼IVF胚囊解凍組合包

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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。

K254261凍結凈化組合包及融解組合包（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速加熱Kitazato Corporation K252672CaseBio™ 綠色培養液/含人血清白蛋白 (CMH5)；CaseBio™ 操控/含人血清白蛋白 (WHH5)Casebioscience, Inc.K250445快速加熱 - NXFujifilm Irvine Scientific K251637Dewin生殖培養基（Dewin配子緩衝液[含HSA和不含HSA]；Dewin卵泡沖洗液，Dewin一步培養基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻化器；超快速加熱器Kitazato Corporation

官方來源

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