Cepheid Xpert GBS LB Control Panel
K号: K182472 · 2018-11-08
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决定日期2018-11-08
产品代码PMN
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器械摘要
Cepheid Xpert GBS LB Control Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K182472. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cepheid Xpert GBS LB Control Panel?
Cepheid Xpert GBS LB Control Panel is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Microbiologics, Inc.. The 510(k) number is K182472.
When did Cepheid Xpert GBS LB Control Panel receive FDA 510(k) clearance?
Cepheid Xpert GBS LB Control Panel received FDA 510(k) clearance on 2018-11-08, under 510(k) number K182472.
Who is the listed applicant for Cepheid Xpert GBS LB Control Panel?
The FDA 510(k) record lists Microbiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cepheid Xpert GBS LB Control Panel?
The FDA product code for Cepheid Xpert GBS LB Control Panel is PMN.
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列明Microbiologics, Inc.为申报人的其他记录
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相关器械（代码：PMN）
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。
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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