ASTar BC G- Kit
K号: K253573 · 2026-04-15
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器械摘要
ASTar BC G- Kit is the device name listed in this FDA 510(k) record. The listed applicant is Q-Linea AB. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K253573. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ASTar BC G- Kit?
ASTar BC G- Kit is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Q-Linea AB. The 510(k) number is K253573.
When did ASTar BC G- Kit receive FDA 510(k) clearance?
ASTar BC G- Kit received FDA 510(k) clearance on 2026-04-15, under 510(k) number K253573.
Who is the listed applicant for ASTar BC G- Kit?
The FDA 510(k) record lists Q-Linea AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASTar BC G- Kit?
The FDA product code for ASTar BC G- Kit is SAN.
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Q-Linea AB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：SAN）
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。
K260160VITEK REVEAL GN AST 测定和 VITEK REVEAL AST 系统bioMerieux, Inc.K253316PhAST仪器和PhAST阴性菌血培养板Phast Corp.K251875LifeScale 革兰氏阴性试剂盒（LSGN）与 LifeScale AST 系统Affinity Biosensors, LLCK241324LifeScale 革兰氏阴性试剂盒（LSGN）与 LifeScale AST 系统Affinity Biosensors, LLCK230675VITEK REVEAL GN AST 测定和 VITEK REVEAL AST 系统Specific Diagnostics, LLCK221688ASTar BC G- Kit和ASTar仪器Q-Linea AB
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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