In Vitro Diagnostic Regeant Set, Cholinesterase

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K914171 ↗

FDA Product Code

DIH

Device Class

Class I

Regulation

21 CFR Part 862.3240

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Cholesterol Regeant Set

  Class I

  FDA 510(k) K914160 Active Cleared 30 Jan 1992

• Lipase Reagent Set

  Class I

  FDA 510(k) K915706 Active Cleared 18 Feb 1992

• Ammonia Reagent Set

  Class I

  FDA 510(k) K915707 Active Cleared 26 Feb 1992

• Glucose Reagent Set

  Class II

  FDA 510(k) K914159 Active Cleared 27 Jan 1992

• Uric Acid Reagent Set

  Class I

  FDA 510(k) K914158 Active Cleared 21 Feb 1992

• Acid Phosphatase Reagent Set

  Class II

  FDA 510(k) K902495 Active Cleared 16 Jul 1990

See all devices from Tech Intl. Co. →