ClearanceBrief
Panels › Immunology › Product code DHB · Class 2

System, Test, Radioallergosorbent (Rast) Immunological

Regulation 866.5750

7510(k)s in 12 months (269 all time)
14recalls in 12 months (27 all time)
16recalls that name a 510(k)
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Top companies in DHB

Company510(k)sRecalls
Pharmacia, Inc.390
Diagnostic Products Corp.260
Hycor Biomedical241
Incstar Corp.250
Phadia AB162
Ventrex Laboratories, Inc.180
Siemens Healthcare Diagnostics98
Immuno Nuclear Corp.140
3M Company130
GET TESTED INTERNATIONAL AB011
Decided510(k)Device and applicantCode
Sep 4, 2026K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
Siemens Healthcare Diagnostics Products, Ltd., GB
DHB
Jul 24, 2026K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellan
Hycor Biomedical
DHB
Jul 21, 2026K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus c
Hycor Biomedical
DHB
Jun 18, 2026K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp
Hycor Biomedical
DHB
May 15, 2026K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Coco
Hycor Biomedical
DHB
Jan 16, 2026K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin
Hycor Biomedical
DHB
Dec 23, 2025K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenari
Hycor Biomedical
DHB
Apr 23, 2025K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Qu
Hycor Biomedical
DHB
Aug 3, 2022K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19
Phadia AB, SE
DHB
Feb 18, 2022K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Hycor Biomedical
DHB
Oct 18, 2021K193613Allergen-Specific IgE Assay 12 Allergen Bundle
Hitachi Chemical Diagnostics, Inc.
DHB
Jun 26, 2020K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Rea
Hycor Biomedical
DHB
May 1, 2020K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
Phadia AB, SE
DHB
Jul 31, 2019K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
Hycor Biomedical
DHB
May 14, 2019K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, Immu
Phadia AB, SE
DHB
Mar 19, 2019K182793AP3600 Automated Instrument
Hitachi Chemical Diagnostics, Inc.
DHB
Dec 4, 2018K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
Hycor Biomedical
DHB
Apr 16, 2018K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
Phadia AB, SE
DHB
May 5, 2017K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
Phadia AB, SE
DHB
Feb 29, 2016K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
Phadia AB, SE
DHB
Jan 19, 2016K151029Phadia Prime
Phadia AB, SE
DHB
Dec 14, 2015K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, W
Phadia AB, SE
DHB
May 28, 2014K132801IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
Siemens Healthcare Diagnostics, Inc.
DHB
Aug 28, 2013K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Phadia US, Inc.
DHB
Jul 10, 2013K131738IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
Phadia AB, SE
DHB
Jun 28, 2013K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
Phadia AB
DHB
Mar 13, 2013K121156AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Phadia AB
DHB
Jan 29, 2013K121463IMMUNOCAP ALLERGEN K82
Thermo Fisher Scientific
DHB
Dec 20, 2012K112910AP 72OS SEMI-AUTOMATED INSTRUMENT
Hitachi Chemical Diagnostics, Inc.
DHB
Sep 13, 2012K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
Phadia US, Inc.
DHB
Jan 6, 2012K112523IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics, Inc.
DHB
Dec 22, 2011K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
Phadia US, Inc.
DHB
Aug 1, 2011K101572IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
DHB
May 27, 2011K101251IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
Phadia AB
DHB
May 11, 2011K100910IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
Siemens Medical Solutions Diagnostics
DHB
Mar 28, 2011K093987IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
Siemens Healthcare Diagnostics, Inc.
DHB
Dec 15, 2010K100999IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
Phadia AB
DHB
Sep 30, 2010K093107IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
DHB
Jan 19, 2010K092978IMMUNOCAP RAPID READER, MODEL 12-3600-10
Phadia US, Inc.
DHB
Nov 20, 2009K092050IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01
Phadia AB
DHB
Oct 28, 2009K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
Siemens Medical Solutions Diagnostics
DHB
Aug 6, 2009K091289IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
DHB
May 26, 2009K090257IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
DHB
Mar 24, 2009K083853IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
DHB
Mar 16, 2009K081830IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1
Phadia AB
DHB
Mar 11, 2009K083314IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
DHB
May 22, 2008K081217HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
Hycor Biomedical, Inc.
DHB
Mar 5, 2008K080322HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
Hycor Biomedical, Inc.
DHB
Aug 24, 2007K071913IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
Phadia AB, SE
DHB
Jan 23, 2006K051677OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
Hitachi Chemical Diagnostics, Inc.
DHB

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