New Allergen Discs for Use in Vast Vent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K830817 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Ventrezyme Vast Immuno-Peroxidase Assay

  Class II

  FDA 510(k) K880547 Active Cleared 25 Mar 1988

• Ace Activity Microvial Test Set

  Class II

  FDA 510(k) K821011 Active Cleared 3 May 1982

• Centria T3 Uptake Test Set

  Not classified

  FDA 510(k) K791050 Active Cleared 15 Jun 1979

• Ventrescreen, Multiple Allergen Discs

  Class II

  FDA 510(k) K841516 Active Cleared 11 May 1984

• Coated Tube HCG Immunoassay HCG

  Class II

  FDA 510(k) K841023 Active Cleared 1 May 1984

• Ventrezyme Beta-Hcg Immunoassay Hcg

  Class II

  FDA 510(k) K841081 Active Cleared 7 May 1984

See all devices from Ventrex Laboratories, Inc. →

• What are New Allergen Discs for Use in Vast Vent?

  New Allergen Discs for Use in Vast Vent are immunology devices used for allergy testing. These discs contain allergens that are applied to patients to test for allergic reactions.

• How are New Allergen Discs supplied?

  The device is supplied by Ventrex Laboratories, Inc. and is authorized under FDA 510(k) clearance K830817. It is a Class II device with product code DGC and is regulated under 21 CFR 866.5510.

• What is the regulatory status of New Allergen Discs?

  New Allergen Discs for Use in Vast Vent has received FDA 510(k) clearance K830817, making it substantially equivalent to predicate devices. It is classified as a Class II device with product code DGC.

• What is the purpose of New Allergen Discs in medical practice?

  These discs are used in immunology for allergy testing, containing specific allergens that are applied to patients to identify allergic reactions. They help clinicians diagnose allergies by observing patient responses to various allergens.