FDA 510(k)

NOVEOS 特异性 IgE (sIgE)，捕获试剂猫屑 - E001，家猫；NOVEOS 特异性 IgE (sIgE)，捕获试剂 Timothy 草 - G006， Timothy 草（Phleum pratense）

K号: K200825 · 2020-06-26

决定日期2020-06-26

产品代码DHB

咨询委员会抱歉，您提供的信息不完整，无法进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200825. 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 Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense?

NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Hycor Biomedical. The 510(k) number is K200825.

When did NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense receive FDA 510(k) clearance?

NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200825.

Who is the listed applicant for NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense?

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 Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense?

The FDA product code for NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense 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。

查看所有 11 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

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。