FDA 510(k)

EliA Rib-P

K号: K202540 · 2021-09-13

决定日期2021-09-13

产品代码MQA

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决定实质等同

器械摘要

EliA Rib-P is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K202540. The device is classified under product code MQA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EliA Rib-P?

EliA Rib-P is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Phadia AB. The 510(k) number is K202540.

When did EliA Rib-P receive FDA 510(k) clearance?

EliA Rib-P received FDA 510(k) clearance on 2021-09-13, under 510(k) number K202540.

Who is the listed applicant for EliA Rib-P?

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 Rib-P?

The FDA product code for EliA Rib-P is MQA.

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 K202541EliA RNA Pol III K202067EliA SmDP-S K200279ImmunoCAP 过敏原 o215，成分 nGal-alpha-1,3-Gal(alpha-Gal) 甲状腺球蛋白，牛

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官方来源

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