Wako Glucose C

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842221 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ammonia Test

  Class I

  FDA 510(k) K813366 Active Cleared 22 Dec 1981

• Wako Triglyceride-G Test

  Class I

  FDA 510(k) K801891 Active Cleared 16 Sep 1980

• Wako Phospholipids Test

  Class I

  FDA 510(k) K801076 Active Cleared 30 Jun 1980

• Wako Triglyceride

  Class I

  FDA 510(k) K791597 Active Cleared 17 Sep 1979

• Wako Hdl Cholesterol Test

  Class I

  FDA 510(k) K801834 Active Cleared 16 Sep 1980