BUHLMANN fCAL ELISA
K号: K181012 · 2018-06-04
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决定日期2018-06-04
产品代码NXO
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器械摘要
BUHLMANN fCAL ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Buhlmann Laboratories AG. It received FDA 510(k) clearance on 2018-06-04 under 510(k) number K181012. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BUHLMANN fCAL ELISA?
BUHLMANN fCAL ELISA is a medical device that received FDA 510(k) clearance on 2018-06-04. The listed applicant is Buhlmann Laboratories AG. The 510(k) number is K181012.
When did BUHLMANN fCAL ELISA receive FDA 510(k) clearance?
BUHLMANN fCAL ELISA received FDA 510(k) clearance on 2018-06-04, under 510(k) number K181012.
Who is the listed applicant for BUHLMANN fCAL ELISA?
The FDA 510(k) record lists Buhlmann Laboratories AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BUHLMANN fCAL ELISA?
The FDA product code for BUHLMANN fCAL ELISA is NXO.
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Buhlmann Laboratories AG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：NXO）
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。
K232057BÜHLMANN fCAL® turbo和CALEX® CapBühlmann Laboratories AGK220763ALPCO 肠钙蛋白免疫浊度测定ALPCOK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.K191807ALPCO 肠钙蛋白化学发光 ELISA, ALPCO 简便粪便提取装置ALPCOK191718Buhlmann fCAL turbo 和 CALEX CapBuhlmann Laboratories AGK191592CalprestNG, EasyCalEurospital S.P.A.
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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