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
Cleared
May 15, 2026
NOVEOS Specific IgE (sIgE)
Hycor Biomedical
Immunology
127d
Cleared
Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
Hycor Biomedical
Immunology
136d
Cleared
Dec 23, 2025
NOVEOS Specific IgE (sIgE)
Hycor Biomedical
Immunology
137d
Cleared
Apr 23, 2025
NOVEOS Specific IgE (sIgE) Assay
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
Phadia AB
Immunology
386d
Cleared
Feb 18, 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Hycor Biomedical
Immunology
29d
Cleared
Oct 18, 2021
Allergen-Specific IgE Assay 12 Allergen Bundle
Hitachi Chemical Diagnostics, Inc.
Immunology
662d
Cleared
Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
Hycor Biomedical
Immunology
88d
Cleared
May 01, 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
Phadia AB
Immunology
87d
Cleared
Jul 31, 2019
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
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
Phadia AB
Immunology
90d
Cleared
Mar 19, 2019
AP3600 Automated Instrument
Hitachi Chemical Diagnostics, Inc.
Immunology
169d
Cleared
Dec 04, 2018
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
Hycor Biomedical
Immunology
85d
Cleared
Apr 16, 2018
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
Phadia AB
Immunology
132d
Cleared
May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
Siemens Healthcare Diagnostics, Inc.
Immunology
257d
Cleared
Jan 29, 2013
IMMUNOCAP ALLERGEN K82
Thermo Fisher Scientific
Immunology
257d
Cleared
Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics, Inc.
Immunology
128d
Cleared
Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
Immunology
423d
Cleared
Mar 28, 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
Siemens Healthcare Diagnostics, Inc.
Immunology
459d
Cleared
Sep 30, 2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
Immunology
364d
Cleared
Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
Immunology
97d
Cleared
May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
Immunology
113d
Cleared
Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
Immunology
90d
Cleared
Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Siemens Healthcare Diagnostics
Immunology
121d
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 →