FDA 510(k)

EliA CENP 免疫测定，EliA U1RNP 免疫测定，EliA RNP70 免疫测定

K号: K182353 · 2018-11-27

决定日期2018-11-27

产品代码LJM

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决定实质等同

器械摘要

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 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 2018-11-27 under 510(k) number K182353. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay?

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay is a medical device that received FDA 510(k) clearance on 2018-11-27. The listed applicant is Phadia AB. The 510(k) number is K182353.

When did EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay receive FDA 510(k) clearance?

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182353.

Who is the listed applicant for EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 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 CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay?

The FDA product code for EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay is LJM.

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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官方来源

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