DHB — System, Test, Radioallergosorbent (Rast) Immunological Class II
FDA product code DHB covers "System, Test, Radioallergosorbent (Rast) Immunological", a Class II medical device regulated under 21 CFR 866.5750. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DHB
- Device Class
- Class II
- Regulation Number
- 866.5750
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260280 | hycor biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Cap | June 18, 2026 |
| K260059 | hycor biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excel | May 15, 2026 |
| K252775 | hycor biomedical | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Cap | January 16, 2026 |
| K252493 | hycor biomedical | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture | December 23, 2025 |
| K242531 | hycor biomedical | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum h | April 23, 2025 |
| K212181 | phadia | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle | August 3, 2022 |
| K220162 | hycor biomedical | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, | February 18, 2022 |
| K193613 | hitachi chemical diagnostics | Allergen-Specific IgE Assay 12 Allergen Bundle | October 18, 2021 |
| K200825 | hycor biomedical | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; | June 26, 2020 |
| K200279 | phadia | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, | May 1, 2020 |
| K191510 | hycor biomedical | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, | July 31, 2019 |
| K190315 | phadia | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e23 | May 14, 2019 |
| K182793 | hitachi chemical diagnostics | AP3600 Automated Instrument | March 19, 2019 |
| K182479 | hycor biomedical | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D | December 4, 2018 |
| K173726 | phadia | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Pe | April 16, 2018 |
| K163370 | phadia | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | May 5, 2017 |
| K150597 | phadia | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | February 29, 2016 |
| K151029 | phadia | Phadia Prime | January 19, 2016 |
| K150854 | phadia | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f4 | December 14, 2015 |
| K132801 | siemens healthcare diagnostics | IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY | May 28, 2014 |