Tina-quant C反应蛋白IV
K号: K192072 · 2020-02-21
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决定日期2020-02-21
产品代码DCN
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器械摘要
Tina-quant C-Reactive Protein IV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K192072. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tina-quant C-Reactive Protein IV?
Tina-quant C-Reactive Protein IV is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K192072.
When did Tina-quant C-Reactive Protein IV receive FDA 510(k) clearance?
Tina-quant C-Reactive Protein IV received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192072.
Who is the listed applicant for Tina-quant C-Reactive Protein IV?
The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tina-quant C-Reactive Protein IV?
The FDA product code for Tina-quant C-Reactive Protein IV is DCN.
相关临床试验
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列明Roche Diagnostics Operations (Rdo)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：DCN）
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。
K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex 试剂盒Siemens Healthcare Diagnostics, Inc.K180099Optilite 高灵敏度C反应蛋白试剂盒The Binding Site Group , Ltd.K172868Optilite C反应蛋白试剂，Optilite C反应蛋白校准液，Optilite C反应蛋白对照品The Binding Site Group , Ltd.K171498MSD CRP 测定试剂盒和 MESO SECTOR S 700 仪器Meso Scale Diagnostics, LLCK161982用于SPAPLUS的C-反应蛋白试剂盒The Binding Site Group
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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