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FDA 510(k)

BioPlex 2200 梅毒总数 & RPR, BioPlex 2200 梅毒总数 & RPR 校准器套件, BioPlex 2200 梅毒总数 & RPR 控制套件

K号: K170413 · 2017-05-11

申请人Bio-Rad Laboratories
决定日期2017-05-11
产品代码LIP
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决定实质等同

器械摘要

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K170413. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set?

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K170413.

When did BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set receive FDA 510(k) clearance?

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set received FDA 510(k) clearance on 2017-05-11, under 510(k) number K170413.

Who is the listed applicant for BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set?

The FDA product code for BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set is LIP.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Bio-Rad Laboratories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。

K183446BioPlex 2200 淋病总数K180577BioPlex 2200 25-OH 维生素 D 试剂盒K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM 校准器套件, BioPlex 2200 ToRC IgM 控制套件K163015Liquichek肿瘤标志物控制级1；Liquichek肿瘤标志物控制级2；Liquichek肿瘤标志物控制级3；Liquichek肿瘤标志物控制-三联级MiniPakK152679Amplichek I，负极，Amplichek I，级别 1，Amplichek I，级别 2，Amplichek I，级别 3，Amplichek I，MiniPak

相关器械（代码：LIP）

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。

K241427Access 梅毒Beckman Coulter, Inc.K241534VITROS 免疫诊断产品 梅毒试剂套装Ortho Clinical DiagnosticsK211302Elecsys 梅毒Roche DiagnosticsK160910Elecsys 梅毒Roche DiagnosticsK153145Lumipulse G TP-N 免疫反应试剂盒Fujirebio Diagnostics,Inc.K153730ARCHITECT 梅毒TP试剂，ARCHITECT 梅毒TP校准器，ARCHITECT 梅毒TP控制Abbott Laboratories

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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