Nein Allergen Disc in Vast Ventrex Test

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K831554 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

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. →