MSD CRP 测定试剂盒和 MESO SECTOR S 700 仪器
K号: K171498 · 2018-01-12
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决定日期2018-01-12
产品代码DCN
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决定实质等同
器械摘要
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Meso Scale Diagnostics, LLC. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171498. 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 MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Meso Scale Diagnostics, LLC. The 510(k) number is K171498.
When did MSD CRP Assay Kit and MESO SECTOR S 700 Instrument receive FDA 510(k) clearance?
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171498.
Who is the listed applicant for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?
The FDA 510(k) record lists Meso Scale Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?
The FDA product code for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is DCN.
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。
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.K192072Tina-quant C反应蛋白IVRoche Diagnostics Operations (Rdo)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.K161982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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