FDA 510(k)

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

Numéro K : K260331 · 2026-09-04

DemandeurSiemens Healthcare Diagnostics Products, Ltd.

Date de décision2026-09-04

Code produitDHB

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K260331. 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 IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K260331.

When did IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) receive FDA 510(k) clearance?

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) received FDA 510(k) clearance on 2026-09-04, under 510(k) number K260331.

Who is the listed applicant for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

The FDA product code for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) is DHB.

Essais cliniques associés

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Autres dossiers indiquant Siemens Healthcare Diagnostics Products, Ltd. en tant que demandeur

K233946IMMULITE® 2000 BR-MA K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA K202826IMMULITE® 2000 Cortisol K203270IMMULITE/IMMULITE® 1000 Cortisol

Dispositifs connexes (Code : DHB)

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 K252493NOVEOS 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

Source officielle

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