K-ASSAY CRP（版本2）
K号: K242170 · 2025-04-18
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决定日期2025-04-18
产品代码DCK
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器械摘要
K-ASSAY CRP (Ver.2) is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Company, LLC. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K242170. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the K-ASSAY CRP (Ver.2)?
K-ASSAY CRP (Ver.2) is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Kamiya Biomedical Company, LLC. The 510(k) number is K242170.
When did K-ASSAY CRP (Ver.2) receive FDA 510(k) clearance?
K-ASSAY CRP (Ver.2) received FDA 510(k) clearance on 2025-04-18, under 510(k) number K242170.
Who is the listed applicant for K-ASSAY CRP (Ver.2)?
The FDA 510(k) record lists Kamiya Biomedical Company, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for K-ASSAY CRP (Ver.2)?
The FDA product code for K-ASSAY CRP (Ver.2) is DCK.
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：DCK）
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。
K201256Procise CRP，ProciseDx 分析仪，ProciseDx 校准卡Procise DiagnosticsK192028优米森C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993优米森C1200 CRPHORIBA ABX SASK160712VITROS 化学产品 hsCRP 试剂Ortho Clinical DiagnosticsK142993QuikRead go CRP，QuikRead go CRP 验证套件，QuikRead go CRP 控制套件，以及 QuikRead go 仪器Orion Diagnostica, OY
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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