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FDA 510(k)

ImmunoCAP 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

K号: K212181 · 2022-08-03

申请人Phadia AB
决定日期2022-08-03
产品代码DHB
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决定实质等同

器械摘要

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2022-08-03 under 510(k) number K212181. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed?

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed is a medical device that received FDA 510(k) clearance on 2022-08-03. The listed applicant is Phadia AB. The 510(k) number is K212181.

When did ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed receive FDA 510(k) clearance?

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed received FDA 510(k) clearance on 2022-08-03, under 510(k) number K212181.

Who is the listed applicant for ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed?

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 ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed?

The FDA product code for ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed is DHB.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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K210902EliA Ro52, EliA Ro60K202540EliA Rib-PK202541EliA RNA Pol IIIK202067EliA SmDP-SK200279ImmunoCAP 过敏原 o215，成分 nGal-alpha-1,3-Gal(alpha-Gal) 甲状腺球蛋白，牛

查看所有 23 个设备 →

相关器械（代码：DHB）

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。

K260331IMMULITE 2000 3g过敏特异性IgE Vantage；IMMULITE 2000系统花生过敏原（F13）Siemens Healthcare Diagnostics Products, Ltd.K261027NOVEOS 特异性IgE（sIgE）；捕获试剂F014，大豆（Glycine max）；捕获试剂F017，榛子（Corylus avellana）；捕获试剂F352，Ara h 8 PR-10，花生；捕获试剂F423，Ara h 2，花生；捕获试剂F447，Ara h 6，花生Hycor BiomedicalK260591NOVEOS 特异性IgE（sIgE）；捕获试剂F010，芝麻（芝麻籽）；捕获试剂F020，杏仁（杏）；捕获试剂F078，牛β-乳球蛋白，牛奶；捕获试剂F080，龙虾（Homarus gammarus）；捕获试剂F422， Ara h 1，花生Hycor BiomedicalK260280NOVEOS 特异性 IgE (sIgE)；捕获试剂 F004，小麦（Triticum aestivum）；捕获试剂 F023，蟹（Callinectes spp.）；捕获试剂 F079，麸质，小麦；捕获试剂 F202，腰果（Anacardium occidentale）；捕获试剂 F233，Gal d 1 卵粘蛋白，鸡蛋Hycor BiomedicalK260059NOVEOS 特异性 IgE (sIgE)；捕获试剂 F018，巴西坚果（Bertholletia excelsa）；捕获试剂 F036，椰子（Cocos nucifera）；捕获试剂 F040，金枪鱼（Thunnus sp.）；捕获试剂 F041，鲑鱼（Salmo salar）；捕获试剂 F075，蛋黄（Gallus gallus）；捕获试剂 F201，碧根果（Carya illinoensis）；捕获试剂 F203，开心果（Pistacia vera）；捕获试剂 F290，牡蛎（Ostrea edulis）Hycor BiomedicalK252775NOVEOS 特异性 IgE (sIgE)：捕获试剂 F013，花生（Arachis hypogaea）；捕获试剂 F076，牛 d 4 α-乳清蛋白，牛奶；捕获试剂 F077，牛 d 5 β-乳球蛋白，牛奶；捕获试剂 F232，Gal d 2 卵白蛋白，鸡蛋Hycor Biomedical

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