ETEST磷霉素（FO）（0.032-512 µg/mL）
K号: K210757 · 2021-11-12
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决定日期2021-11-12
产品代码JWY
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决定实质等同
器械摘要
ETEST Fosfomycin (FO) (0.032-512 µg/mL) 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 2021-11-12 under 510(k) number K210757. 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 Fosfomycin (FO) (0.032-512 µg/mL)?
ETEST Fosfomycin (FO) (0.032-512 µg/mL) is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Biomerieux S.A.. The 510(k) number is K210757.
When did ETEST Fosfomycin (FO) (0.032-512 µg/mL) receive FDA 510(k) clearance?
ETEST Fosfomycin (FO) (0.032-512 µg/mL) received FDA 510(k) clearance on 2021-11-12, under 510(k) number K210757.
Who is the listed applicant for ETEST Fosfomycin (FO) (0.032-512 µg/mL)?
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 ETEST Fosfomycin (FO) (0.032-512 µg/mL)?
The FDA product code for ETEST Fosfomycin (FO) (0.032-512 µg/mL) is JWY.
相关临床试验
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。
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。
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 SAK260696MTS 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 ScientificK250575Sensititre 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 ScientificK252014Sensititre 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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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