FDA 510(k)

VIDAS B.R.A.H.M.S. PCT（PCT）

K号: K160911 · 2016-06-28

决定日期2016-06-28

产品代码PMT

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决定实质等同

器械摘要

VIDAS B.R.A.H.M.S. PCT (PCT) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2016-06-28 under 510(k) number K160911. The device is classified under product code PMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VIDAS B.R.A.H.M.S. PCT (PCT)?

VIDAS B.R.A.H.M.S. PCT (PCT) is a medical device that received FDA 510(k) clearance on 2016-06-28. The listed applicant is bioMerieux, Inc.. The 510(k) number is K160911.

When did VIDAS B.R.A.H.M.S. PCT (PCT) receive FDA 510(k) clearance?

VIDAS B.R.A.H.M.S. PCT (PCT) received FDA 510(k) clearance on 2016-06-28, under 510(k) number K160911.

Who is the listed applicant for VIDAS B.R.A.H.M.S. PCT (PCT)?

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 VIDAS B.R.A.H.M.S. PCT (PCT)?

The FDA product code for VIDAS B.R.A.H.M.S. PCT (PCT) is PMT.

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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