Glucose Hexokinase

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880236 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alt (Sgpt) Reagent Set

  Class I

  FDA 510(k) K880275 Active Cleared 1 Mar 1988

• Creatine Kinase (Ck) Reagent Set

  Class II

  FDA 510(k) K881237 Active Cleared 28 Apr 1988

• Triglyceride

  Class I

  FDA 510(k) K880238 Active Cleared 15 Mar 1988

• Urea Nitrogen (Bun)

  Class II

  FDA 510(k) K880078 Active Cleared 11 Feb 1988

• Magnesium Reagent Set

  Class I

  FDA 510(k) K882256 Active Cleared 8 Aug 1988

• Total Bilirubin Reagent

  Class II

  FDA 510(k) K881241 Active Cleared 27 May 1988

See all devices from Tech-Neal Scientific, Inc. →