FDA 510(k)

NOVEOS 特异性 IgE (sIgE)；捕获试剂 F024，虾（Shrimp spp.）；捕获试剂 F207，蛤蜊（Mercenaria mercenaria）；捕获试剂 F256，核桃（Juglans spp.）；捕获试剂 I006，德国臭虫（Blatella germanica）

K号: K252493 · 2025-12-23

决定日期2025-12-23

产品代码DHB

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决定实质等同

器械摘要

NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K252493. 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 F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)?

When did NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) receive FDA 510(k) clearance?

Who is the listed applicant for NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)?

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 F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)?

The FDA product code for NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) 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

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