DHB · Class II · 21 CFR 866.5750

FDA Product Code DHB: System, Test, Radioallergosorbent (rast) Immunological

Leading manufacturers include Diagnostic Products Corp., 3M Company and Hycor Biomedical.

265
Total
265
Cleared
109d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 160d recently vs 108d historically

FDA 510(k) Cleared System, Test, Radioallergosorbent (rast) Immunological Devices (Product Code DHB)

265 devices
1–24 of 265
Cleared May 15, 2026
NOVEOS Specific IgE (sIgE)
K260059
Hycor Biomedical
Immunology · 127d
Cleared Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775
Hycor Biomedical
Immunology · 136d
Cleared Dec 23, 2025
NOVEOS Specific IgE (sIgE)
K252493
Hycor Biomedical
Immunology · 137d
Cleared Apr 23, 2025
NOVEOS Specific IgE (sIgE) Assay
K242531
Hycor Biomedical
Immunology · 240d
Cleared Aug 03, 2022
ImmunoCAP 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 seed
K212181
Phadia AB
Immunology · 386d
Cleared Feb 18, 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
K220162
Hycor Biomedical
Immunology · 29d
Cleared Oct 18, 2021
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613
Hitachi Chemical Diagnostics, Inc.
Immunology · 662d
Cleared Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
K200825
Hycor Biomedical
Immunology · 88d
Cleared May 01, 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
K200279
Phadia AB
Immunology · 87d
Cleared Jul 31, 2019
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
K191510
Hycor Biomedical
Immunology · 55d
Cleared May 14, 2019
ImmunoCAP 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 Cat
K190315
Phadia AB
Immunology · 90d
Cleared Mar 19, 2019
AP3600 Automated Instrument
K182793
Hitachi Chemical Diagnostics, Inc.
Immunology · 169d
Cleared Dec 04, 2018
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
K182479
Hycor Biomedical
Immunology · 85d
Cleared Apr 16, 2018
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
K173726
Phadia AB
Immunology · 132d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152
Diagnostic Products Corp.
Immunology · 85d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208
Diagnostic Products Corp.
Immunology · 44d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
K013135
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
K013134
Diagnostic Products Corp.
Immunology · 26d
Cleared Dec 17, 1998
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954
Diagnostic Products Corp.
Immunology · 42d
Cleared Sep 29, 1997
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
K973186
Diagnostic Products Corp.
Immunology · 35d
Cleared Nov 18, 1996
IMMULITE LATEX-SPECIFIC IGE
K963245
Diagnostic Products Corp.
Immunology · 91d
Cleared Oct 10, 1996
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS
K961889
Diagnostic Products Corp.
Immunology · 147d
Cleared Dec 18, 1995
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM
K954566
Diagnostic Products Corp.
Immunology · 77d

About Product Code DHB - Regulatory Context

510(k) Submission Activity

265 total 510(k) submissions under product code DHB since 1977, with 265 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DHB Product Code

Recent submissions under DHB have taken an average of 160 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.

DHB devices are reviewed by the Immunology panel. Browse all Immunology devices →