FDA 510(k)

CHROMID CARBA 琼脂 (CARB)

K号: K181092 · 2018-07-06

决定日期2018-07-06

产品代码JSO

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决定实质等同

器械摘要

CHROMID CARBA agar (CARB) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K181092. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CHROMID CARBA agar (CARB)?

CHROMID CARBA agar (CARB) is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Biomerieux S.A.. The 510(k) number is K181092.

When did CHROMID CARBA agar (CARB) receive FDA 510(k) clearance?

CHROMID CARBA agar (CARB) received FDA 510(k) clearance on 2018-07-06, under 510(k) number K181092.

Who is the listed applicant for CHROMID CARBA agar (CARB)?

The FDA 510(k) record lists Biomerieux S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMID CARBA agar (CARB)?

The FDA product code for CHROMID CARBA agar (CARB) is JSO.

列明Biomerieux S.A.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。

K250274ETEST亚胺培南/雷贝拉坦铜绿假单胞菌（IRPA）（0.008/4-128/4 µg/mL）K210757ETEST磷霉素（FO）（0.032-512 µg/mL）K192738ETEST去甲氟雷酸（DFX）（0.002-32 µg/mL）K192050ETEST厄他环素（ERV）（0.002-32 µg/mL）K191953ETEST亚胺培南/雷贝拉坦（IPR）（0.002/4-32/4 µg/mL）K190154ETEST哌拉西林/他唑巴坦（P/T）（0.016/4-256/4 µg/mL）

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