Model Ucg Assay

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822520 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ovu Stick Urine Hlh Kit

  Class I

  FDA 510(k) K840412 Active Cleared 13 Apr 1984

• Plus Urine Hcg Assay

  Class II

  FDA 510(k) K840738 Active Cleared 19 Apr 1984

• B-Clone HCG Assay

  Class II

  FDA 510(k) K831155 Active Cleared 2 Jun 1983

• Ovustick Self-Test

  Class I

  FDA 510(k) K843284 Active Cleared 11 Dec 1984

• Ramp Herpes Simplex Virus (Hsv) (Cct)

  Class II

  FDA 510(k) K874863 Active Cleared 16 Feb 1988

• Pregnastick Urine Hcg Kit

  Class II

  FDA 510(k) K833504 Active Cleared 9 Jan 1984

See all devices from Monoclonal Antibodies, Inc. →