FDA 510(k)

Sensititre 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。

K号: K252062 · 2025-09-25

决定日期2025-09-25

产品代码JWY

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决定实质等同

器械摘要

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K252062. 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 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL?

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K252062.

When did The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL receive FDA 510(k) clearance?

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL received FDA 510(k) clearance on 2025-09-25, under 510(k) number K252062.

Who is the listed applicant for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL?

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

What is the FDA product code for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL?

The FDA product code for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL is JWY.

列明Thermo Fisher Scientific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。

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。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。K250990Sensititre 18-24小时MIC或断裂点敏感性系统，含环丙沙星，稀释范围为0.002-64 μg/mL。K242843Sensititre 20-24小时流感嗜血杆菌/肺炎链球菌（HP）MIC或断裂点敏感性系统，含头孢匹罗，稀释范围为0.008-16 μg/mL。K242659Sensititre 18-24小时MIC或断裂点敏感性系统，含万古霉素，稀释范围为0.25-128 μg/mL。K242658Sensititre 18-24小时MIC或断裂点敏感性系统，含莫西沙星，稀释范围为0.008-16 μg/mL。

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