FDA.reportPublic FDA data

510(k) K193613

Device
Allergen-Specific IgE Assay 12 Allergen Bundle
Applicant
Hitachi Chemical Diagnostics, Inc.
510(k) number
K193613
Product code
DHB
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-18
Date received
2019-12-26
Regulation
866.5750
Classification name
System, Test, Radioallergosorbent (Rast) Immunological
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Christina Kong
Address
630 Clyde Ct. Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DHB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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 Biomedical2026-05-15
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 Biomedical2026-01-16
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 Biomedical2025-12-23
K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay AnalyzHycor Biomedical2025-04-23
K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seedPhadia AB2022-08-03
K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaHycor Biomedical2022-02-18
K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratenseHycor Biomedical2020-06-26
K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovinePhadia AB2020-05-01
K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinaeHycor Biomedical2019-07-31
K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 CatPhadia AB2019-05-14
K182793AP3600 Automated InstrumentHitachi Chemical Diagnostics, Inc.2019-03-19
K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinusHycor Biomedical2018-12-04
K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutPhadia AB2018-04-16
K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEPhadia AB2017-05-05
K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mitePhadia AB2016-02-29