FDA product code DHB: System, Test, Radioallergosorbent (Rast) Immunological
DHB is the FDA product code for system, test, radioallergosorbent (rast) immunological. It is a Class II device, regulated under 21 CFR 866.5750 and reviewed by the Immunology panel. FDA has cleared 269 510(k) submissions under DHB, 10 in the last five years, from 42 different applicants. The average 510(k) review took 110 days (median 77); 168 days on average over the last three years. FDA has posted 27 recalls for DHB devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Radioallergosorbent (Rast) Immunological |
| Device class | Class II |
| Regulation | 21 CFR 866.5750 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DHB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 155 |
| 2018 | 2 | 108 |
| 2019 | 3 | 105 |
| 2020 | 2 | 88 |
| 2021 | 1 | 662 |
| 2022 | 2 | 208 |
| 2025 | 2 | 188 |
| 2026 | 6 | 147 |
Compare with all 510(k) review times · Search every DHB clearance
Top DHB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmacia, Inc. | 39 | 1998-02-09 |
| Diagnostic Products Corp. | 26 | 2002-12-17 |
| Incstar Corp. | 25 | 1988-06-14 |
| Ventrex Laboratories, Inc. | 18 | 1992-03-13 |
| Phadia AB | 16 | 2022-08-03 |
37 more applicants have DHB clearances. See the full list in Caduvo.
Most recent DHB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260331 | Siemens Healthcare Diagnostics Products, Ltd. | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | 2026-09-04 | 214 |
| K261027 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | 2026-07-24 | 116 |
| K260591 | Hycor Biomedical | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | 2026-07-21 | 148 |
| K260280 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | 2026-06-18 | 140 |
| K260059 | Hycor Biomedical | NOVEOS 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) | 2026-05-15 | 127 |
Recalls for DHB devices
27 product recalls in 12 recall events; 17 initiated in the last five years and 18 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 1 |
| 2022 | 3 |
| 2025 | 14 |
Frequently asked questions
What is FDA product code DHB?
DHB is the FDA product code for system, test, radioallergosorbent (rast) immunological. It is a Class II device, regulated under 21 CFR 866.5750 and reviewed by the Immunology panel.
What device class is DHB?
Class II, regulation 21 CFR 866.5750. Typical premarket route: 510(k).
How long does a 510(k) take for product code DHB?
Across 269 cleared submissions the average was 110 days from receipt to decision (median 77).
Which companies have the most DHB clearances?
Pharmacia, Inc. (39); Diagnostic Products Corp. (26); Incstar Corp. (25); Ventrex Laboratories, Inc. (18); Phadia AB (16).
Have DHB devices been recalled?
Yes: 27 product recalls across 12 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code DHB
- Run a recall and safety report across every DHB manufacturer
- Watch product code DHB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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