FDA 510(k)

VITEK MS PRIME

K号: K212461 · 2022-03-15

决定日期2022-03-15

产品代码QBN

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决定实质等同

器械摘要

VITEK MS PRIME is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2022-03-15 under 510(k) number K212461. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITEK MS PRIME?

VITEK MS PRIME is a medical device that received FDA 510(k) clearance on 2022-03-15. The listed applicant is bioMerieux, Inc.. The 510(k) number is K212461.

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

VITEK MS PRIME received FDA 510(k) clearance on 2022-03-15, under 510(k) number K212461.

Who is the listed applicant for VITEK MS PRIME?

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 PRIME?

The FDA product code for VITEK MS PRIME is QBN.

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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