DHB · Class II · 21 CFR 866.5750

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

Leading manufacturers include Pharmacia, Inc., Diagnostic Products Corp. and Incstar Corp..

268
Total
268
Cleared
109d
Avg days
1977
Since
Growing category - 7 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 149d recently vs 108d historically

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

268 devices
1–24 of 268
Cleared Jul 24, 2026
NOVEOS Specific IgE (sIgE)
K261027
Hycor Biomedical
Immunology · 116d
Cleared Jul 21, 2026
NOVEOS Specific IgE (sIgE)
K260591
Hycor Biomedical
Immunology · 148d
Cleared Jun 18, 2026
NOVEOS Specific IgE (sIgE)
K260280
Hycor Biomedical
Immunology · 140d
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 May 05, 2017
ImmunoCAP Allergen w1, Common ragweed
K163370
Phadia AB
Immunology · 155d
Cleared Feb 29, 2016
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
K150597
Phadia AB
Immunology · 357d
Cleared Jan 19, 2016
Phadia Prime
K151029
Phadia AB
Immunology · 277d
Cleared Dec 14, 2015
ImmunoCAP Specific IgE
K150854
Phadia AB
Immunology · 258d
Cleared May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801
Siemens Healthcare Diagnostics, Inc.
Immunology · 257d
Cleared Aug 28, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
K122197
Phadia US, Inc.
Immunology · 400d
Cleared Jul 10, 2013
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
K131738
Phadia AB
Immunology · 27d

About Product Code DHB - Regulatory Context

510(k) Submission Activity

268 total 510(k) submissions under product code DHB since 1977, with 268 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 0 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 149 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 →