FDA 510(k)

ETEST®舒巴坦/杜洛巴坦（SUD）（0.004/4-64/4 µg/mL），ETEST® SUD

K号: K232395 · 2023-10-05

决定日期2023-10-05

产品代码JWY

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决定实质等同

器械摘要

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K232395. 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 ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Biomérieux. The 510(k) number is K232395.

When did ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD receive FDA 510(k) clearance?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD received FDA 510(k) clearance on 2023-10-05, under 510(k) number K232395.

Who is the listed applicant for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

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

What is the FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

The FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is JWY.

列明Biomérieux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。

K250856ETEST阿奇霉素/阿维巴坦（AZA）（0.016/4-256/4 µg/mL）

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

官方来源

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