Elecsys CA 15-3 II
K号: K171605 · 2018-02-20
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决定日期2018-02-20
产品代码MOI
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器械摘要
Elecsys CA 15-3 II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-02-20 under 510(k) number K171605. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Elecsys CA 15-3 II?
Elecsys CA 15-3 II is a medical device that received FDA 510(k) clearance on 2018-02-20. The listed applicant is Roche Diagnostics. The 510(k) number is K171605.
When did Elecsys CA 15-3 II receive FDA 510(k) clearance?
Elecsys CA 15-3 II received FDA 510(k) clearance on 2018-02-20, under 510(k) number K171605.
Who is the listed applicant for Elecsys CA 15-3 II?
FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Elecsys CA 15-3 II?
The FDA product code for Elecsys CA 15-3 II is MOI.
相关临床试验
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列明Roche Diagnostics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：MOI）
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。
K240403Access BR监测器Beckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 测定Siemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche Diagnostics
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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