Serum Cholinesterase Reagent Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K833062 ↗

FDA Product Code

DLI

Device Class

Class I

Regulation

21 CFR Part 862.3240

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Lactic Dehydrogenase Reagent Set

  Class II

  FDA 510(k) K831415 Active Cleared 16 Jun 1983

• Alt/Gpt Reagent Set

  Class I

  FDA 510(k) K844251 Active Cleared 8 Jan 1985

• Glucose(Hexokinase) Reagent Set

  Class II

  FDA 510(k) K844998 Active Cleared 18 Jan 1985

• Ast/Got Reagent Set UV Rate

  Class II

  FDA 510(k) K842521 Active Cleared 12 Aug 1984

• Total Cholesterol Reagent Set

  Class I

  FDA 510(k) K820950 Active Cleared 26 Apr 1982

• Hydroxybutyrate Dehydrogenase Reagent

  Class I

  FDA 510(k) K834084 Active Cleared 4 Feb 1984

See all devices from Sterling Biochemical, Inc. →