BioCode® 呼吸道病原体检测板 (RPP)
K号: K254139 · 2026-05-01
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决定日期2026-05-01
产品代码OCC
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器械摘要
BioCode® Respiratory Pathogen Panel (RPP) is the device name listed in this FDA 510(k) record. The listed applicant is Applied BioCode, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K254139. 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 BioCode® Respiratory Pathogen Panel (RPP)?
BioCode® Respiratory Pathogen Panel (RPP) is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Applied BioCode, Inc.. The 510(k) number is K254139.
When did BioCode® Respiratory Pathogen Panel (RPP) receive FDA 510(k) clearance?
BioCode® Respiratory Pathogen Panel (RPP) received FDA 510(k) clearance on 2026-05-01, under 510(k) number K254139.
Who is the listed applicant for BioCode® Respiratory Pathogen Panel (RPP)?
The FDA 510(k) record lists Applied BioCode, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioCode® Respiratory Pathogen Panel (RPP)?
The FDA product code for BioCode® Respiratory Pathogen Panel (RPP) 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Applied BioCode, 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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