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FDA 510(k)

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

K-Number: K100910 · 2011-05-11

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2011-05-11
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2011-05-11 under 510(k) number K100910. 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 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6?

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 is a medical device that received FDA 510(k) clearance on 2011-05-11. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K100910.

When did IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 receive FDA 510(k) clearance?

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 received FDA 510(k) clearance on 2011-05-11, under 510(k) number K100910.

Who is the listed applicant for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6?

The FDA 510(k) record lists Siemens Medical Solutions Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6?

The FDA product code for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 is DHB.

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Other records listing Siemens Medical Solutions Diagnostics 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.

K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORSK071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265K072658ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSK072794IMMULITE 2500 OM-MA, MODEL L5KOP

View all 11 devices →

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.

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 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 Biomedical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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