FDA 510(k)

Liofilchem MIC 测试条 (MTS), Delafloxacin 0.002 - 32 ug/mL

K号: K180886 · 2018-05-18

决定日期2018-05-18

产品代码JWY

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决定实质等同

器械摘要

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180886. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL?

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K180886.

When did Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL receive FDA 510(k) clearance?

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180886.

Who is the listed applicant for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL?

The FDA product code for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL is JWY.

列明Liofilchem s.r.l.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。

K260696MTS 丙硫异烟胺 0.016-256 µg/mL K252114MTS 阿齐霉素-阿维巴坦 0.016/4 - 256/4 µg/mL K251580MTS 氨苄西林-杜洛巴坦 0.004/4 - 64/4 µg/mL (SUD)K243202MTS 头孢托泊 0.002-32 µg/mL K230479ComASP Cefiderocol 0.008-128 K211672MTS 哌拉西林-他唑巴坦 0.016/4 - 256/4µg/mL

查看所有 35 个设备 →

相关器械（代码：JWY）

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。

K260447ETEST吉普他汀（GEP）（0.016-256 µg/mL）bioMérieux SA K260696MTS 丙硫异烟胺 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS 阿齐霉素-阿维巴坦 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062Sensititre 18-24小时MIC或断裂点敏感性系统，含多粘菌素，稀释范围为0.12-16 μg/mL。Thermo Fisher Scientific K250575Sensititre 18-24小时MIC或断裂点敏感性系统，含阿奇霉素/阿维巴坦，稀释范围为0.008/4 - 64/4 μg/mL。Thermo Fisher Scientific K252014Sensititre 18-24小时MIC或断裂点敏感性系统，含阿米卡星，稀释范围为0.25-256 μg/mL。Thermo Fisher Scientific

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