Accula RSV Test
K号: K181443 · 2018-11-23
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决定日期2018-11-23
产品代码OCC
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器械摘要
Accula RSV Test is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K181443. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Accula RSV Test?
Accula RSV Test is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Mesa Biotech, Inc.. The 510(k) number is K181443.
When did Accula RSV Test receive FDA 510(k) clearance?
Accula RSV Test received FDA 510(k) clearance on 2018-11-23, under 510(k) number K181443.
Who is the listed applicant for Accula RSV Test?
The FDA 510(k) record lists Mesa Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Accula RSV Test?
The FDA product code for Accula RSV Test is OCC.
相关临床试验
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列明Mesa Biotech, Inc.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：OCC）
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。
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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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