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FDA 510(k)

ImmunoCAP 总 IgE 校准条/总 IgE 曲线对照条，ImmunoCAP 总 IgE 校准器/总 IgE 曲线对照，ImmunoCAP 特异性 IgE 校准条/特异性 IgE 曲线对照条，ImmunoCAP 特异性 IgE 校准器/特异性 IgE 曲线对照

K号: K161899 · 2016-07-28

申请人Phadia AB
决定日期2016-07-28
产品代码DGC
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决定实质等同

器械摘要

ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161899. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls?

ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Phadia AB. The 510(k) number is K161899.

When did ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls receive FDA 510(k) clearance?

ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161899.

Who is the listed applicant for ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls?

The FDA 510(k) record lists Phadia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls?

The FDA product code for ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls is DGC.

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Phadia AB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。

K253367EliA CTD 13 屏幕检测K212181ImmunoCAP 过敏原 f433，过敏原成分 rTri a 14 LTP，小麦，ImmunoCAP 过敏原 f416，过敏原成分 rTri a 19 Omega-5 谷蛋白，小麦，ImmunoCAP 过敏原 f449，过敏原成分 rSes i 1 芝麻籽K210902EliA Ro52, EliA Ro60K202540EliA Rib-PK202541EliA RNA Pol IIIK202067EliA SmDP-S

查看所有 23 个设备 →

相关器械（代码：DGC）

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。

K231151Kenota 1 总 IgE；Kenota 1（仪器）Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178总免疫球蛋白E（IgE）Beckman Coulter, Inc.K193493ADVIA Centaur 总IgE (tIgE)Siemens Healthcare Diagnostics, Inc.

官方来源

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