FDA 510(k)

EliA PR3s 免疫测定；EliA MPOs 免疫测定；EliA GBM 免疫测定

K号: K173792 · 2018-03-13

决定日期2018-03-13

产品代码MOB

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决定实质等同

器械摘要

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM 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 2018-03-13 under 510(k) number K173792. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is a medical device that received FDA 510(k) clearance on 2018-03-13. The listed applicant is Phadia AB. The 510(k) number is K173792.

When did EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay receive FDA 510(k) clearance?

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay received FDA 510(k) clearance on 2018-03-13, under 510(k) number K173792.

Who is the listed applicant for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM 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 PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

The FDA product code for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is MOB.

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

查看所有 23 个设备 →

相关器械（代码：MOB）

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。

K261466Alegria闪光MPO；Alegria闪光PR3；Alegria闪光GBMZeus Scientific K243776抗中性粒细胞胞浆抗体（乙醇固定）；抗中性粒细胞胞浆抗体（福尔马林固定）Zeus Scientific K172582EUROIMMUN IFA 粒细胞镶嵌™ EUROPattern 和 EUROIMMUN EUROPLUS 粒细胞镶嵌™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA ̼, AESKUSLIDES ANCAAesku.Diagnostics GmbH & Co. KG K161258NOVA Lite DAPI ANCA 乙醇试剂盒，NOVA Lite DAPI ANCA 甲醛试剂盒Inova Diagnostics, Inc.

官方来源

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