Mast Luminescent Allergy System
FDA 510(k) K844629 · Mast Immunosystems
510(k) numberK844629
Submission
- Device name
- Mast Luminescent Allergy System
- Applicant
- Mast Immunosystems
Mountain View, CA, US - Received
- November 27, 1984
- Decision date
- April 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
Other 510(k)s with product code DHB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 09/04/2026SE |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…DHB · Traditional | Hycor Biomedical | 07/24/2026SE |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…DHB · Traditional | Hycor Biomedical | 07/21/2026SE |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…DHB · Traditional | Hycor Biomedical | 06/18/2026SE |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…DHB · Traditional | Hycor Biomedical | 05/15/2026SE |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…DHB · Traditional | Hycor Biomedical | 01/16/2026SE |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…DHB · Traditional | Hycor Biomedical | 12/23/2025SE |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…DHB · Traditional | Hycor Biomedical | 04/23/2025SE |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | Phadia AB | 08/03/2022SE |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB · Traditional | Hycor Biomedical | 02/18/2022SE |
More from Hycor Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K934524 | Mast Cla Allergy SystemDHB · Traditional | 03/07/1994SE |
| K926420 | Mast Cla Allergy SystemDHB · Traditional | 03/07/1994SE |
| K914850 | Chemiluminescent System Allergan Specific IgeDHB · Traditional | 12/09/1991SE |
| K910292 | Mast Cla Allergy SystemDHB · Traditional | 04/05/1991SE |
| K870966 | Total Ige MastickDHB · Traditional | 04/14/1987SE |
| K843694 | Mast Allergy SystemDHB · Traditional | 04/12/1985SE |
| K841642 | Mast Luminescent Allergy SysDGC · Traditional | 06/07/1984SE |
| K834526 | Mast Inhalant ProfileDHB · Traditional | 04/04/1984SE |
| K833969 | Mast Total IgeDGC · Traditional | 01/04/1984SE |
| K833885 | Mast Inhalant ProfileDHB · Traditional | 01/04/1984SE |
Questions and answers
When was Mast Luminescent Allergy System cleared by the FDA?
Mast Luminescent Allergy System (K844629) received a 510(k) decision of Substantially Equivalent on April 12, 1985, 136 days after the submission was received.
What is the product code of K844629?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.