FDA 510(k)

VITEK MS

K号: K162950 · 2017-07-22

决定日期2017-07-22

产品代码PEX

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决定实质等同

器械摘要

VITEK MS is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-07-22 under 510(k) number K162950. The device is classified under product code PEX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITEK MS?

VITEK MS is a medical device that received FDA 510(k) clearance on 2017-07-22. The listed applicant is bioMerieux, Inc.. The 510(k) number is K162950.

When did VITEK MS receive FDA 510(k) clearance?

VITEK MS received FDA 510(k) clearance on 2017-07-22, under 510(k) number K162950.

Who is the listed applicant for VITEK MS?

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 MS?

The FDA product code for VITEK MS is PEX.

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）

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