Leap Le Test Kit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K842484 ↗

FDA Product Code

LKJ

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Demand Magnesium

  Class I

  FDA 510(k) K851657 Active Cleared 10 May 1985

• Demand Total Protein

  Class II

  FDA 510(k) K863301 Active Cleared 26 Sep 1986

• Ion Selective Electrode

  Class I

  FDA 510(k) K841076 Active Cleared 7 May 1984

• Radial Immunodiffusion Plates C3 & C4

  Class II

  FDA 510(k) K851286 Active Cleared 5 Jun 1985

• Radial Immunodiffusion Plates-Ceruloplasmin

  Class II

  FDA 510(k) K851283 Active Cleared 23 May 1985

• Demand C02

  Class II

  FDA 510(k) K841726 Active Cleared 7 Jun 1984

See all devices from Cooper Biomedical, Inc. →