FDA 510(k)

EliA RF IgM 免疫测定

K号: K182747 · 2018-12-18

决定日期2018-12-18

产品代码DHR

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决定实质等同

器械摘要

EliA RF IgM Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182747. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EliA RF IgM Immunoassay?

EliA RF IgM Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Phadia AB. The 510(k) number is K182747.

When did EliA RF IgM Immunoassay receive FDA 510(k) clearance?

EliA RF IgM Immunoassay received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182747.

Who is the listed applicant for EliA RF IgM Immunoassay?

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 EliA RF IgM Immunoassay?

The FDA product code for EliA RF IgM Immunoassay is DHR.

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 Ro60 K202540EliA Rib-P K202541EliA RNA Pol III K202067EliA SmDP-S

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