FilmArray 呼吸检测板 2 (RP2)
K号: K170604 · 2017-05-30
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决定日期2017-05-30
产品代码OCC
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器械摘要
FilmArray Respiratory Panel 2 (RP2) is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K170604. 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 FilmArray Respiratory Panel 2 (RP2)?
FilmArray Respiratory Panel 2 (RP2) is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K170604.
When did FilmArray Respiratory Panel 2 (RP2) receive FDA 510(k) clearance?
FilmArray Respiratory Panel 2 (RP2) received FDA 510(k) clearance on 2017-05-30, under 510(k) number K170604.
Who is the listed applicant for FilmArray Respiratory Panel 2 (RP2)?
The FDA 510(k) record lists Biofire Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FilmArray Respiratory Panel 2 (RP2)?
The FDA product code for FilmArray Respiratory Panel 2 (RP2) is OCC.
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Biofire Diagnostics, LLC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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