Allergen Discs
by Kallestad Laboratories, Inc. 4 variants
510(k) K823470
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823470 | Date15 Dec 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Allercoat Allergen Discs
- 510(k) Number
- FDA Product Code
- DHB
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5750
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Allergen Discs are a system, test, radioallergosorbent (Rast) immunological device. The device is classified as a Class 2 device with product code DHB. It is used in the field of immunology.
The Allergen Discs are supplied by Kallestad Laboratories, Inc. and have been cleared through the Traditional 510(k) pathway. The device has FDA 510(k) clearance, with the referenced clearance number being K823470. The device is intended for use in immunological testing.
Other devices from Kallestad Laboratories, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Allergen Discs device used for?
The Allergen Discs device is used for immunological testing, specifically radioallergosorbent testing, in the field of immunology.
How is the Allergen Discs device supplied?
The Allergen Discs device is supplied by Kallestad Laboratories, Inc.
What is the regulatory status of the Allergen Discs device?
The Allergen Discs device has FDA 510(k) clearance, with the referenced clearance number being K823470, and is classified as a Class 2 device with product code DHB.