FDA 510(k)

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE

K-번호: K163370 · 2017-05-05

결정일2017-05-05

제품 코드DHB

자문 위원회IM

결정Substantially Equivalent

기기 요약

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K163370. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Phadia AB. The 510(k) number is K163370.

When did ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE receive FDA 510(k) clearance?

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE received FDA 510(k) clearance on 2017-05-05, under 510(k) number K163370.

Who is the listed applicant for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?

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 w1, Common ragweed; ImmunoCAP Specific IgE?

The FDA product code for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is DHB.

Phadia AB를 신청인으로 등재한 기타 기록

K253367EliA CTD 13 Screen K212181ImmunoCAP 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 K210902EliA Ro52, EliA Ro60 K202540EliA Rib-P K202541EliA RNA Pol III K202067EliA SmDP-S

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관련 기기 (코드: DHB)

K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd.K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, PeanutHycor Biomedical K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, PeanutHycor Biomedical K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid EggHycor Biomedical K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)Hycor Biomedical K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, EggHycor Biomedical

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