FDA 510(k)

VITEK COMPACT PRO

K号: K234012 · 2025-03-14

决定日期2025-03-14

产品代码LON

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决定实质等同

器械摘要

VITEK COMPACT PRO is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K234012. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITEK COMPACT PRO?

VITEK COMPACT PRO is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is bioMerieux, Inc.. The 510(k) number is K234012.

When did VITEK COMPACT PRO receive FDA 510(k) clearance?

VITEK COMPACT PRO received FDA 510(k) clearance on 2025-03-14, under 510(k) number K234012.

Who is the listed applicant for VITEK COMPACT PRO?

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 COMPACT PRO?

The FDA product code for VITEK COMPACT PRO is LON.

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）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）K240279VIDAS TBI（GFAP，UCH-L1）

查看所有 65 个设备 →

相关器械（代码：LON）

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。

K260282VITEK 2 AST-诱导克林霉素耐药性链球菌bioMerieux, Inc.K260281VITEK 2 AST-链球菌头孢呋辛（<=0.125 - >=8 µg/mL）BIOMERIEUX K251579VITEK 2 AST-革兰氏阴性头孢唑啉（=<1-=>32 µg/mL）bioMerieux, Inc.K251713BD Phoenix 自动微生物学系统 - GN 恩拉韦环素（0.125-2 µg/mL）Becton, Dickinson and Company K250447BD Phoenix® 自动微生物学系统 - GN 亚胺培南-雷巴匹坦（0.0625/4 - 16/4 µg/mL）Becton, Dickinson and Company K250344BD Phoenix® 自动微生物学系统Becton, Dickinson and Company

官方来源

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