FDA 510(k)

EliA B2-糖蛋白 I IgA 免疫测定，EliA 心磷脂 IgA 免疫测定

K号: K181329 · 2018-06-25

决定日期2018-06-25

产品代码MSV

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决定实质等同

器械摘要

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA 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 2018-06-25 under 510(k) number K181329. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Phadia AB. The 510(k) number is K181329.

When did EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay receive FDA 510(k) clearance?

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay received FDA 510(k) clearance on 2018-06-25, under 510(k) number K181329.

Who is the listed applicant for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA 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 B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

The FDA product code for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is MSV.

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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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。