FDA 510(k)

Noveos 免疫分析仪系统，Noveos 特异性 IgE (slgE)，捕获试剂 D002，Dermatophagoides farinae

K号: K191510 · 2019-07-31

决定日期2019-07-31

产品代码DHB

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决定实质等同

器械摘要

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191510. 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 Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae?

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Hycor Biomedical. The 510(k) number is K191510.

When did Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae receive FDA 510(k) clearance?

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191510.

Who is the listed applicant for Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae?

FDA 510(k)记录显示Hycor Biomedical为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae?

The FDA product code for Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae is DHB.

列明Hycor Biomedical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。

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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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