FDA 510(k)

ImmunoCAP 特异性 IgE，ImmunoCAP 过敏原 f447，过敏原成分 rAra h 6，花生

K号: K173726 · 2018-04-16

决定日期2018-04-16

产品代码DHB

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决定实质等同

器械摘要

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-04-16 under 510(k) number K173726. 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 Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut?

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is a medical device that received FDA 510(k) clearance on 2018-04-16. The listed applicant is Phadia AB. The 510(k) number is K173726.

When did ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut receive FDA 510(k) clearance?

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut received FDA 510(k) clearance on 2018-04-16, under 510(k) number K173726.

Who is the listed applicant for ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut?

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 Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut?

The FDA product code for ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is DHB.

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：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 Biomedical K260591NOVEOS 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 Biomedical K260280NOVEOS 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 Biomedical K260059NOVEOS 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 Biomedical K252775NOVEOS 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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