Decision Date2017-05-05
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
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.
Frequently Asked Questions
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.
Other records listing Phadia AB as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: DHB)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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 BiomedicalK260591NOVEOS 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 BiomedicalK260280NOVEOS 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 BiomedicalK260059NOVEOS 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 BiomedicalK252775NOVEOS 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 BiomedicalK252493NOVEOS 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)Hycor Biomedical
Official Source
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