FDA 510(k)

冷凍頂體凍結組合包及冷凍頂體解凍組合包

K 號：K160864 · 2016-10-07

決定日期2016-10-07

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

Cryotop Vitrification Kit and Cryotop Thawing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Biopharma Co., Ltd.. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K160864. 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 Cryotop Vitrification Kit and Cryotop Thawing Kit?

Cryotop Vitrification Kit and Cryotop Thawing Kit is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Kitazato Biopharma Co., Ltd.. The 510(k) number is K160864.

When did Cryotop Vitrification Kit and Cryotop Thawing Kit receive FDA 510(k) clearance?

Cryotop Vitrification Kit and Cryotop Thawing Kit received FDA 510(k) clearance on 2016-10-07, under 510(k) number K160864.

Who is the listed applicant for Cryotop Vitrification Kit and Cryotop Thawing Kit?

The FDA 510(k) record lists Kitazato Biopharma Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cryotop Vitrification Kit and Cryotop Thawing Kit?

The FDA product code for Cryotop Vitrification Kit and Cryotop Thawing Kit is MQL.

其他以 Kitazato Biopharma Co., 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。

K160863PBS(-), 磷酸鹽緩衝鹽 K160142礦物油 K153027冷凍頂US

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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