DHB
- Product code
- DHB
- Device name
- System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5750
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 268 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261027 | 2026-07-24 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F014, So… | |
| K260591 | 2026-07-21 | Hycor Biomedical | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Ses… | |
| K260280 | 2026-06-18 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wh… | |
| K260059 | 2026-05-15 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Br… | |
| K252775 | 2026-01-16 | Hycor Biomedical | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Pe… | |
| K252493 | 2025-12-23 | Hycor Biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Sh… | |
| K242531 | 2025-04-23 | Hycor Biomedical | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G0… |
Official FDA classification page: DHB
Classification and pathway per current FDA publications. Data from openFDA (CC0).