FDA 510(k)

MTS 莱法米林 0.016- 256 µg/mL

K号: K200308 · 2020-04-06

决定日期2020-04-06

产品代码JWY

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决定实质等同

器械摘要

MTS Lefamulin 0.016- 256 µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem S. R. 1.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K200308. 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 MTS Lefamulin 0.016- 256 µg/mL?

MTS Lefamulin 0.016- 256 µg/mL is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Liofilchem S. R. 1.. The 510(k) number is K200308.

When did MTS Lefamulin 0.016- 256 µg/mL receive FDA 510(k) clearance?

MTS Lefamulin 0.016- 256 µg/mL received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200308.

Who is the listed applicant for MTS Lefamulin 0.016- 256 µg/mL?

The FDA 510(k) record lists Liofilchem S. R. 1. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Lefamulin 0.016- 256 µg/mL?

The FDA product code for MTS Lefamulin 0.016- 256 µg/mL is JWY.

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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器械摘要

常见问题

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相关器械（代码：JWY）

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