Atlas FDA

IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)

FDA 510(k) clearance K013134 · decided 2001-10-15

Clearance details

K-number
K013134
Device name
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
Applicant
Diagnostic Products Corp.
Decision
Substantially Equivalent
Date received
2001-09-19
Decision date
2001-10-15
Days to decision
26 days
Clearance type
Special
Product code
DHB
Device class
2
Regulation number
866.5750
Medical specialty
Immunology
Advisory committee
Immunology
Location
Los Angeles, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
NOVEOS 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, Peanut (K261027)Hycor Biomedical2026-07-24
NOVEOS 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, Peanut (K260591)Hycor Biomedical2026-07-21
NOVEOS 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 Egg (K260280)Hycor Biomedical2026-06-18
NOVEOS 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) (K260059)Hycor Biomedical2026-05-15
NOVEOS 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, Egg (K252775)Hycor Biomedical2026-01-16
NOVEOS 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) (K252493)Hycor Biomedical2025-12-23
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Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria (K220162)Hycor Biomedical2022-02-18
Allergen-Specific IgE Assay 12 Allergen Bundle (K193613)Hitachi Chemical Diagnostics, Inc.2021-10-18
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense (K200825)Hycor Biomedical2020-06-26
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine (K200279)Phadia AB2020-05-01

Recalls involving this device

RecordFirmDate
IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit recall (Z-1674-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Sie recall (Z-1843-2015)Siemens Healthcare Diagnostics, Inc.2015-06-25