FDA 510(k)

Essai d'IgE spécifique aux allergènes 12 Ensemble d'allergènes

Numéro K : K193613 · 2021-10-18

DemandeurHitachi Chemical Diagnostics, Inc.

Date de décision2021-10-18

Code produitDHB

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

Allergen-Specific IgE Assay 12 Allergen Bundle is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K193613. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Allergen-Specific IgE Assay 12 Allergen Bundle?

Allergen-Specific IgE Assay 12 Allergen Bundle is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K193613.

When did Allergen-Specific IgE Assay 12 Allergen Bundle receive FDA 510(k) clearance?

Allergen-Specific IgE Assay 12 Allergen Bundle received FDA 510(k) clearance on 2021-10-18, under 510(k) number K193613.

Who is the listed applicant for Allergen-Specific IgE Assay 12 Allergen Bundle?

The FDA 510(k) record lists Hitachi Chemical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allergen-Specific IgE Assay 12 Allergen Bundle?

The FDA product code for Allergen-Specific IgE Assay 12 Allergen Bundle is DHB.

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Autres dossiers indiquant Hitachi Chemical Diagnostics, Inc. en tant que demandeur

K182793Instrument automatique AP3600

Dispositifs connexes (Code : 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

Source officielle

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