Identifiers
- 510(k) Number
- K922538 FDA 510(k)
- FDA Product Code
- DHB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ventrex Allergen Disc is a system, test, radioallergosorbent (Rast) immunological device. It is used for immunological testing. The device is classified as a class 2 device. The medical specialty description for this device is Immunology.
The Ventrex Allergen Disc is supplied with a product code of DHB. It has received FDA 510(k) clearance, with clearance numbers including K922538. The device is manufactured by Hycor Biomedical, Inc. and has a registration number, including 1036362 and 3031570369. The device is regulated under regulation number 866.5750.
Frequently asked questions
What is the Ventrex Allergen Disc used for?
The Ventrex Allergen Disc is used for immunological testing, specifically as a radioallergosorbent test system.
What is the classification of the Ventrex Allergen Disc?
The Ventrex Allergen Disc is classified as a class 2 device, regulated under regulation number 866.5750.
What is the product code for the Ventrex Allergen Disc?
The product code for the Ventrex Allergen Disc is DHB.
Has the Ventrex Allergen Disc received FDA clearance?
Yes, the Ventrex Allergen Disc has received FDA 510(k) clearance, with clearance number K922538.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VENTREX ALLERGEN DISC (K924209) — FDA 510(k) | Innolitics, VENTREX ALLERGEN DISC (K922538) — FDA 510(k) | Innolitics, VENTREX ALLERGEN DISC 510 (k) K924044 - FDA.report, PDF K924209 VENTREX ALLERGEN DISC - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922538 | Class II | Active |
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Manufacturer
- Manufacturer
- Hycor Biomedical, Inc.
Sources (1)
- FDA 510(k) K922538 24 fields · synced Oct 1, 2026