Maple Allergen Disc
FDA 510(k) K862266 · Immuno Nuclear Corp.
510(k) numberK862266
Submission
- Device name
- Maple Allergen Disc
- Applicant
- Immuno Nuclear Corp.
Stillwater, MN, US - Received
- June 13, 1986
- Decision date
- August 19, 1986
- 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 |
|---|---|---|
| K863743 | Biotech's Ige Immuno Response Test Isotope UnitDHB · Traditional | 12/15/1986SE |
| K863973 | Elm Allergen DiscDHB · Traditional | 12/01/1986SE |
| K863844 | Immuno Biotech's Lamb's Quarters Allergen DiscDHB · Traditional | 10/29/1986SE |
| K863123 | Immuno Biotech Mugwart Allergen DiscDHB · Traditional | 10/01/1986SE |
| K863098 | Meadow Fescue Allergen DiscDHB · Traditional | 09/15/1986SE |
| K862939 | Orchard Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862938 | June Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862265 | Cottonwood Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862176 | Russian Thistle Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862174 | Timothy Allergen DiscDGC · Traditional | 08/06/1986SE |
Questions and answers
When was Maple Allergen Disc cleared by the FDA?
Maple Allergen Disc (K862266) received a 510(k) decision of Substantially Equivalent on August 19, 1986, 67 days after the submission was received.
What is the product code of K862266?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.