FDA 510(k)

VITEK 2 AST-酵母米卡芬净（0.06-8 μg/mL）

K号: K151923 · 2016-03-25

决定日期2016-03-25

产品代码NGZ

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决定实质等同

器械摘要

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K151923. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)?

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is bioMerieux, Inc.. The 510(k) number is K151923.

When did VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) received FDA 510(k) clearance on 2016-03-25, under 510(k) number K151923.

Who is the listed applicant for VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)?

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

What is the FDA product code for VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)?

The FDA product code for VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) is NGZ.

列明bioMerieux, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260160VITEK REVEAL GN AST 测定和 VITEK REVEAL AST 系统 K260282VITEK 2 AST-诱导克林霉素耐药性链球菌 K251579VITEK 2 AST-革兰氏阴性头孢唑啉（=<1-=>32 µg/mL）K234012VITEK COMPACT PRO K232967VITEK 2 AST-酵母伏立康唑（<= 0.03125 - >= 4 µg/mL）K232963VITEK 2 AST-酵母阿尼鲁兰（<= 0.015 - >= 8 µg/mL）

查看所有 65 个设备 →

相关器械（代码：NGZ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243738The Sensititre YeastOne 敏感性系统，含有米卡芬净，稀释范围为0.008-16 µg/mLThermo Fisher Scientific K232967VITEK 2 AST-酵母伏立康唑（<= 0.03125 - >= 4 µg/mL）bioMerieux, Inc.K232963VITEK 2 AST-酵母阿尼鲁兰（<= 0.015 - >= 8 µg/mL）bioMerieux, Inc.K231433The Sensititre YeastOne 敏感性系统，含有雷扎芬净，稀释范围为0.008-8ug/mLThermo Fisher Scientific K221198Sensititre YeastOne敏感性系统，含Fluconazole，稀释范围为0.12-128ug/mLThermo Fisher Scientific K221899The Sensititre YeastOne 敏感性系统，含有卡泊芬净，稀释范围为0.015-16ug/mlThermo Fisher Scientific

官方来源

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